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What are clinical trials.

Clinical trials are scientific studies that involve people in research and are the only way to advance cancer treatment. Before people are given a new intervention, it is carefully studied in the laboratory. Studies with the most promising results are then moved into clinical trials with people. Clinical trials are used to evaluate new and better ways to treat, prevent, detect, diagnose, and manage symptoms of cancer.

How do I know if I am eligible for a trial?

Once you locate a trial/s of interest through our  search engine  (via conditions or eligibility), or mobile app ( iOS  |  Android ), click through to the trial’s detail page. Scroll down and review the “Eligibility” section. All clinical trials have guidelines about who can take part. Anyone who wants to take part must fit the guidelines to be in the study (called the inclusion and exclusion criteria). These usually relate to age and gender, cancer type and stage, other medical conditions you may have and the types of treatments already undergone.

Once you have located a study in which you feel you reasonably meet the eligibility criteria, contact the study team directly.  On the trial’s detail page you will find “contact information” listed on the right hand side of the page.

After contacting the study team you may be pre-screened prior to an in-person consultation with a study physician who determines if you are eligible for the trial.

·         The study team may ask you questions over the phone though their pre-screening process.

·         You may be asked to set up an appointment through New Patient Coordinator for an in-person consultation with a study physician to determine eligibility and treatment options. The New Patient Coordinator phone number is (650) 498-6000.

If after reading study descriptions you find it difficult to decide which study is appropriate, discuss the study with your oncologist or make an appointment for a second opinion at Stanford to find out about all potential treatment options. To make an appointment, please call the Stanford Cancer Center New Patient Coordinator at 650-498-6000.

What questions should I ask before joining a cancer clinical trial?

You should ask many questions so you can best decide if joining a trial is right for you. Here are some questions you may want to consider… More

What does it cost to participate in a trial?

There are two types of costs:

1) Routine care costs 

2) Research costs. Health insurance typically covers the cost of the routine care. 

These are costs that would incur whether or not you were in a clinical trial. However, you will still be responsible for any co-payments and/or deductibles. Research costs for the research portion of a trial are paid for by the trial itself at no cost to you. However, there may be additional costs, such as personal time and travel expenses, which may or may not be covered by a clinical trial. Please be aware that each trial is unique. The study team will go over the costs of participation with you before you agree to participate.

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Need help finding a trial?

If you are interested in applying for a clinical trial or have questions, an associate is available to provide information and assist you with the application process. Feel free to reach out for further guidance and support.

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Meet CRI’s New CEO Alicia Zhou, PhD

Cancer Clinical Trials

Find cancer clinical trials.

Cancer immunotherapy clinical trials are critical to bringing new and potentially lifesaving treatments to more patients with more types of cancer, and may represent the greatest hope for those currently facing the disease. Immunotherapy is increasingly available in clinical trials for early-stage cancers or as a first-line treatment option as clinical research rapidly progresses. Many patients, however, are not aware of recent breakthroughs in immunotherapy research and the growing opportunities to participate in new cancer clinical trials. Without this information, patients may find it difficult to identify cancer clinical trials that may be appropriate for them.

Our Cancer Immunotherapy Clinical Trial Finder will aid you in finding your answer to cancer. Understand the basics of cancer clinical trials, why clinical trials are so critical to our work, what things to consider about enrolling, and how to assist patients in finding clinical trials for which they may be eligible.

Access cutting-edge cancer treatments

• Hundreds of new and promising cancer immunotherapy treatments are only available to patients in clinical trials . Participating in clinical trials of these therapies may be the most promising option for cancer patients today, and will be critical to speeding the development and approval of new drugs for more patients in the future.
• Only 3% to 6% percent of cancer patients who are eligible for clinical trials participate; this slows the clinical development process significantly and means that more than 90% of cancer patients may be missing out on potentially life-saving new treatments .
• Many cancer patients are not aware of immunotherapy clinical trials because their doctors do not inform them about these opportunities. We encourage patients to educate themselves about cancer clinical trials , as well as to use our Cancer Immunotherapy Clinical Trial Finder to be matched with clinical trials, and to talk with their doctors about participating.

Drive scientific research

• There are still many unmet needs in cancer , especially for patients with advanced, metastatic disease. In recent years, immunotherapies have succeeded in achieving complete and durable remissions in some patients with cancers previously considered incurable.
• Many patients may be hesitant about participating in a cancer clinical trial for fear that the treatment may be too risky, or that the side effects may be severe. Cancer clinical trials are generally safe . Immunotherapy side effects may be different from those associated with conventional cancer treatments because they result from an overstimulated or misdirected immune response rather than the direct effect of a chemical or radiological therapy on cancer and healthy tissues. Clinical trials are vital for doctors to understand how to identify and manage side effects.
• Some patients may believe that they will receive a ‘placebo’ (not an active drug) in place of treatment in cancer clinical trials. Patients will always receive treatment on a clinical trial if an approved treatment already exists. Most clinical trials do not include a placebo. In a few cases, placebos may be used in addition to standard treatment to determine whether additional medicine may have a greater or lesser impact in their care.
• Clinical trials don’t just test new treatments. Cancer clinical trials provide insight into the best way to administer existing treatments. For example, a combination of two therapies may work better than a single therapy, or a lower drug dosage may be just as effective in shrinking tumors, but with less severe side effects.

Help future cancer patients

• Clinical trials are an essential part of the cancer care continuum. When you enroll in a cancer clinical trial, you are part of a team , including doctors, nurses, trial coordinators, and fellow patients.
• Immunotherapy represents a completely new approach to cancer treatment . By participating in an immunotherapy clinical trial, you have the opportunity not only to access a potentially lifesaving treatment, but also to help advance this new approach and bring immunotherapies to more patients in the future.
• The U.S. Food and Drug Administration has approved immunotherapies to treat many different cancer types. These drugs are now standard-of-care for many cancers thanks to cancer clinical trials and the patients who participated in them.

Explore more cancer clinical trial information

• Register for a CRI Immunotherapy Patient Summit to learn about cancer clinical trials from experts and hear from patients about their clinical trial experiences directly. Get more detailed information about the clinical trials process.
• Watch videos in the ‘Ask a Scientist: Cancer Immunotherapy Clinical Trials’ series with Michael Postow, MD, of Memorial Sloan Kettering Cancer Center.
• Figure out what questions you should ask about the cancer clinical trial process .
• Learn more about immunotherapy for different types of cancer .
• Discover clinical trials being supported by CRI’s Clinical Accelerator program .
• Watch ‘Cancer Immunotherapy and You’ webinars about cancer clinical trials, such as ‘Patient to Patient: What You Need to Know About Cancer Immunotherapy’ and ‘Finding an Immunotherapy Clinical Trial with Patrick Meins, Clinical Trial Navigator’ .
• Benefit from additional resources for cancer patients , including common terminology and community support .
• Download cancer clinical trial resources from the National Cancer Institute .

Create a Profile

Find a Clinical Trial

Use our Cancer Immunotherapy Clinical Trial Finder to work with a Clinical Trial Navigator and match with clinical trials that might be right for you.

If you have additional questions, contact the Clinical Trial Finder team at [email protected] or contact Cancer Research Institute at [email protected] .

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The Sidney Kimmel Comprehensive Cancer Center

Cancer clinical trials.

Clinical trials are an important part of the Johns Hopkins Kimmel Cancer Center's treatment options. Every treatment available today started as  a clinical trial.

Clinical trials, also known as studies, offer new treatment options for cancer patients. There are many different kinds of clinical trials. Your oncologist can describe the studies that may be a fit for you. Don't be afraid to ask questions! Our doctors and nurses understand that there is a lot to consider when making decisions about treatment including participating in a clinical trial. Our videos help explain clinical trials so you and your healthcare team can make the choice that's right for you.

At the Kimmel Cancer Center, our experts recognize that cancer is a complex disease, and each patient is unique. To ensure that every patient receives treatment recommendations that are tailored precisely to their cancer, we request that those who are interested in one of our clinical trials, and who are not already a patient at the Kimmel Cancer Center, schedule a new patient consultation. To do this, please call 410-955-8964 , and select option 2.

ClinicalTrials.gov Search Cancer Clinical Trials

Find information about studies offered at the Johns Hopkins Kimmel Cancer Center by using the ClinicalTrials.gov search below.

Power In Choices 

Clinical trials: hope and anticipation.

Learn more about the hope clinical trials can bring to cancer patients present and in the future at the Johns Hopkins Kimmel Cancer Center.

Clinical Trials: Expectations, Realities & Challenges

Meet a group of cancer patients who have taken part in clinical trials at the Johns Hopkins Kimmel Cancer Center. Learn about their expectations, realities and challenges they faced in joining a clinical trial.

Clinical Trials: Words & Phrases

Learn more and lessen fear about clinical trials at the Johns Hopkins Kimmel Cancer Center, by understanding the vocabulary and purpose of cancer clinical trials...

FEATURED CLINICAL TRIAL PRISMM

Patient Response to Immunotherapy using Spliceosome Mutational Markers or PRISMM is a Johns Hopkins trial for patients with advanced breast cancer whose tumors have been sequenced and have a spliceosome mutation (SF3B1)

Clinical Trials Resources

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Clinical trials: A significant part of cancer care

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By Mayo Clinic staff

A cancer diagnosis is an emotional experience. Learning that you have cancer can create feelings of hopelessness, fear and sadness. This is especially true if your cancer is advanced or available treatments are unable to stop or slow its growth.

"Often, when patients are diagnosed with cancer , they feel hopeless and scared. Clinical trials are one way patients can be proactive. They can make a choice in how their care is going to be," says Matthew Block, M.D., Ph.D. , a Mayo Clinic medical oncologist.

Cancer clinical trials help physician-scientists test new and better ways to control and treat cancer. During a clinical trial, participants receive specific interventions, and researchers determine if those interventions are safe and effective. Interventions studied in clinical trials might be new cancer drugs or new combinations of drugs, new medical procedures, new surgical techniques or devices, new ways to use existing treatments, and lifestyle or behavior changes.

Clinical trials provide access to potential treatments under investigation, giving options to people who otherwise may face limited choices. "Clinical trials open the door to a new hope that maybe we can fight their cancer back and give them a better quality of life," says Geoffrey Johnson, M.D., Ph.D. , a Mayo Clinic radiologist, nuclear medicine specialist and co-chair of the Mayo Clinic Comprehensive Cancer Center Experimental and Novel Therapeutics Disease Group.

You will receive cancer treatment if you participate in a clinical trial. "I think one common misperception about clinical trials is that if you enter a clinical trial, you may not get treatment (receive a placebo). And that's actually very much not true. Most clinical trials are looking at one treatment compared to another treatment," says Judy C. Boughey, M.D. , a Mayo Clinic surgical oncologist, chair of Breast and Melanoma Surgical Oncology at Mayo Clinic in Rochester, Minnesota, and chair of the Mayo Clinic Comprehensive Cancer Center Breast Cancer Disease Group.

"I think one common misperception about clinical trials is that if you enter a clinical trial, you may not get treatment (receive a placebo). And that's actually very much not true. Most clinical trials are looking at one treatment compared to another treatment." Judy C. Boughey, M.D.

Watch this video to hear the experiences of people who have participated in cancer clinical trials and to hear Drs. Block, Johnson and Boughey discuss the importance of clinical trials in cancer care:

Clinical trials are a significant part of cancer care at Mayo Clinic Comprehensive Cancer Center. Cancer care teams work together across specialties to make sure the right clinical trials are available to serve the needs of people with cancer who come to Mayo Clinic.

"We are very particular in how we select the clinical trials that we have available for patients," says Dr. Boughey. "We want to have the best trials available for our patients. Some of the clinical trials are evaluating drugs — we are so excited about those drugs, but we can't prescribe those drugs for patients without having that trial. And so we will actually fight to try to get that trial open here to have it available as an opportunity for our patients."

If you choose to participate in a clinical trial, you will continue to receive cancer care. "For most patients that we evaluate, there's always the standard of care treatment option for those patients. And then, in many situations, there's also a clinical trial that the patient can participate in," says Dr. Boughey.

People who participate in clinical trials help make new and better cancer care available for future patients. The treatments available for cancer patients today exist because of the clinical trial participants of yesterday. "We couldn't advance medicine if it wasn't for people volunteering for trials. And the promise from our side is to say we're not going to put patients on trials or offer trials for them to consider unless we think there's a good chance that they'll get a benefit or that society at large will get a benefit," says Dr. Johnson.

"We couldn't advance medicine if it wasn't for people volunteering for trials. And the promise from our side is to say we're not going to put patients on trials or offer trials for them to consider unless we think there's a good chance that they'll get a benefit or that society at large will get a benefit." Geoffrey Johnson, M.D., Ph.D.

Participating in a clinical trial may give you access to cutting-edge treatment, improve your quality of life and extend your time with loved ones.

"It's definitely worth reaching out to your healthcare provider and asking, 'What clinical trials could I be a potential candidate for?'" says Dr. Boughey. "And remember, you can ask this of your surgical oncologist, your medical oncologist, your radiation oncologist, or any of the physicians you're seeing because there are trials in all disciplines. There are also ongoing trials that require the collection of tissue or the donation of blood. They can also be important in trying to help future generations as we continue to work to end cancer."

Participating in a clinical trial is an important decision with potential risks and benefits. Explore these FAQ about cancer clinical trials, and ask your care team if a clinical trial might be right for you.

Learn more about cancer clinical trials and find a clinical trial at Mayo Clinic.

Join the Cancer Support Group on Mayo Clinic Connect , an online community moderated by Mayo Clinic for patients and caregivers.

Read these articles about people who have participated in clinical trials at Mayo Clinic:

• A silent tumor, precancerous polyps and the power of genetic screening
• Mayo Clinic’s DNA study reveals BRCA1 mutations in 3 sisters, prompts life-changing decisions

Read more articles about Mayo Clinic cancer research made possible by people participating in clinical trials.

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Cancer Research & Clinical Trials

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Knowing all you can about clinical trials can help you feel more certain when deciding whether to take part in one. The information in this section addresses many questions and concerns about clinical trials. It can help prepare you to discuss the pros and cons with your doctor and your family and decide whether being in a clinical trial is right for you.

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A Phase 1b Study of AMG 193 Plus mFOLFIRINOX or With Gemcitabine and Nab-paclitaxel in People With Advanced Pancreatic Cancer

Researchers want to learn if AMG 193 in combination with standard treatment is safe for people with advanced pancreatic cancer. The people in this study have pancreatic ductal adenocarcinoma (PDAC) that has metastasized (spread). In addition, their cancers have a mutation (change) in the MTAP gene. This results in a lack of the MTAP protein, which may help cancer grow.

In this study, researchers will find the best dose of AMG 193 for further testing. If you join this study, you will get one of these treatments:

• AMG 193 + gemcitabine + nab-paclitaxel
• AMG 193 + mFOLFIRINOX

AMG 193 is taken orally (by mouth) and the other medications are given intravenously (by vein).

Who Can Join

To join this study, there are a few conditions. You must:

• Have metastatic PDAC and not have received anti-cancer medications for advanced disease.
• Have PDAC that lacks MTAP.
• Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
• Be age 18 or older.

For more information or to see if you can join this study, please call Dr. Eileen O’Reilly’s office at 646-888-4182 .

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Trastuzumab Deruxtecan Shows Promise in HER2+ BC with Brain Metastases

Christos Evangelou

September 15, 2024

A study demonstrated the efficacy of trastuzumab deruxtecan (Enhertu) in patients with HER2- positive advanced or metastatic breast cancer, including those with brain metastases . 

Senior author Nancy Lin, MD, presented these primary results of the DESTINY-Breast12 trial at the European Society for Medical Oncology Congress 2024. These findings were published simultaneously in the journal Nature Medicine . 

Brain metastases are a significant concern in HER2-positive breast cancer, affecting approximately half of patients with metastatic disease, said Lin, of the Dana-Farber Cancer Institute in Boston. Historically, these patients have faced limited treatment options and poor prognoses, she continued.

"Although tucatinib -based regimens can be effective, the median progression-free survival in patients with brain metastases in the HER2CLIMB clinical trial was less than 8 months, and additional effective treatment options are needed," she said. That trial compared tucatinib vs placebo in combination with capecitabine and trastuzumab in patients with advanced HER2+ breast cancer .

The DESTINY-Breast12 study , a phase 3b/4 multicenter, open-label trial, aimed to address this critical unmet need.

Study Design and Patient Population  

DESTINY-Breast12 enrolled 504 patients, with 263 in the brain metastases cohort and 241 in the non-brain metastases cohort. Patients received trastuzumab deruxtecan (T-DXd) at a dose of 5.4 mg/kg intravenously every 3 weeks. The primary endpoints were progression-free survival (PFS) for the brain metastases cohort and objective response rate (ORR) for the non-brain metastases cohort.

Lin explained that of the 263 patients with brain metastases, 157 had stable brain metastases, and 106 had active brain metastases. Of the patients with active brain metastases, 39 had previously untreated disease, and 67 had previously treated but progressive disease at study entry.

The study included patients who had received zero to two prior lines of therapy in the metastatic setting, with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Lin emphasized that patients who received prior tucatinib-based therapy were excluded. Approximately two thirds of patients had hormone receptor-positive disease, and the majority had measurable disease.

Cristina Saura Manich, MD, PhD, head of the Breast Cancer Unit of the Service of Medical Oncology at Vall d'Hebron University Hospital in Barcelona, emphasized the importance of this study. "This not only provided access to the drug in countries where it was not yet reimbursed, but also enabled professionals to gain experience in managing the drug in the clinical trial setting." She also noted that the study provides crucial evidence for a population with limited treatment options, particularly those with active brain metastases. Manich was not involved with the DESTINY-Breast12 trial and served as study discussant.

Efficacy of T-DXd in HER2+ Advanced or Metastatic BC

Lin reported promising results for patients with brain metastases. The 12-month PFS was 61.6% (95% CI, 54.9% - 67.6%) after treatment with T-DXd, with a median PFS of 17.3 months (95% CI, 13.7 - 22.1). This outcome was consistent across patients with both stable and active brain metastases, she said.

The 12-month central nervous system (CNS) PFS was 58.9% (95% CI, 51.9% - 65.3%) overall, and it was also consistent between stable and active brain metastases groups.

According to Lin, the intracranial objective response rate was particularly noteworthy, with 71.7% of patients with measurable CNS disease at baseline showing a response. This rate was 79.2% in patients with stable brain metastases and 62.3% in those with active brain metastases. 

"Looking carefully at the patients with active brain metastases, the response rate in the brain was 82.6% in those with previously untreated disease," she noted. 

For patients without brain metastases, the ORR was 62.7% (95% CI, 56.5% - 68.8%), which, according to Lin, "aligns with previous phase 3 trastuzumab deruxtecan trials in this setting."

When restricting the analysis to patients with measurable disease at baseline, the ORR increased to 68.4% (95% CI, 62.2% - 74.6%).

The 12-month overall survival (OS) rate was high in both cohorts, reaching 90.3% in patients with brain metastases and 90.6% in patients without brain metastases. Median OS was not reached at the time of data cutoff.

Safety of Trastuzumab Deruxtecan in Trial

According to Lin, the safety profile of T-DXd was consistent with previous reports, with no new safety signals identified. Grade 3 or higher adverse events occurred in approximately half of the patients in both cohorts, she noted, during her presentation. 

Lin added that treatment discontinuation due to toxicity was relatively uncommon, occurring in 15.2% of patients with brain metastases and 9.5% of patients without brain metastases.

According to data presented by Lin, interstitial lung disease (ILD) remains an important risk after treatment with T-DXd, occurring in 16% of patients in the brain metastases cohort and 12.9% in the non-brain metastases cohort. There were six cases of grade 5 ILD in patients with brain metastases, with four of these cases reported as co-occurring with opportunistic infections. 

T-DXd demonstrated promising efficacy in this setting. But Lin cautioned that "careful attention to pneumocystis pneumonia prophylaxis and workup for opportunistic infections is warranted, particularly in patients with brain metastases on concomitant steroids."

Clinical Implications and Future Work

Lin emphasized the significance of these findings.

"Results from DESTINY-Breast12 support the use of T-DXd for patients with HER2-positive metastatic breast cancer, irrespective of the presence or absence of stable or active brain metastases," she said.

Comparing the DESTINY-Breast12 results to previous studies, Manich commented, "The HER2CLIMB study, which led to the approval of the triplet of tucatinib, trastuzumab, and capecitabine in combination for this indication, is the only randomized study with a significant number of patients with active brain metastases that reported statistically positive and clinically meaningful results." 

She added that the evidence for T-DXd in this population had been limited until now.

Manich concluded the discussion by suggesting potential changes to treatment recommendations based on these results.

"After today's presentation, I believe the preferred option for second-line treatment should now be trastuzumab deruxtecan, regardless of whether the patient has active brain metastases or not. Additionally, for third-line treatment, the preferred option would be tucatinib, trastuzumab, and capecitabine in my opinion."

She also highlighted the importance of future real-world data analysis, stating, "It will be very important to perform real-world data analysis to understand the efficacy of tucatinib in this setting after progression to trastuzumab deruxtecan."

Manich reported financial relationships with AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Daiichi Sankyo, Eisai, Exact Sciences, Exeter Pharma, F. Hoffmann-La Roche Ltd, Gilead, Lilly, Merck Sharp & Dohme, Novartis, Pfizer, Philips, Pierre Fabre, Pint-Pharma, Puma, Roche Farma, sanofi-aventis, Seagen, Zymeworks, Genentech, Innoup, Millenium, and Pharmalex Spain SLU (advisory board); Sociedade Portuguesa de Oncología (invited speaker); AstraZeneca, Bayer Pharma, Boehringer Ingelheim, Bristol Myers Squibb, CytomX Therapeutics, Daiichi Sankyo, Eli Lilly, F. Hoffmann-La Roche Ltd, Genentech, GSK, Immunomedics, Innoup Farma, Macrogenics, Menarini Ricerche, Merus, Novartis, Pfizer, Puma, Roche, sanofi-aventis, and Seattle Genetics (institutional research grant); and Byondis B.V. (coordinating PI). 

Lin reported financial relationships with Artera, AstraZeneca, Blueprint Medicines, Daiichi Sankyo, Eisai, Janssen, Olema Pharmaceuticals, Seagen, and Stemline Therapeutics (consulting or advisory roles); Olema Pharmaceuticals (travel support); AstraZeneca, Genentech, Olema Pharmaceuticals, Pfizer, Seagen, and Zion (institutional research support); and UpToDate (royalties for book chapters). 

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Enfortumab Vedotin Effective in Patients With Urothelial Cancer Outside of Clinical Trials

Enfortumab vedotin showed a robust disease control rate in patients with urothelial cancer outside of a clinical trial, and its efficacy was not inferior in patients with diabetes and/or neuropathy.

Enfortumab vedotin (EV) was associated with a robust disease control rate in patients with advanced urothelial carcinoma (aUC) outside of clinical trials, and it showed similar efficacy in patients with and without neuropathy or diabetes, according to posters presented at the European Society for Medical Oncology Congress 2024 .

The first poster 1 was aimed at assessing the efficacy of EV combined with pembrolizumab (EV/P), as the combination had previously been shown to improve outcomes in patients with aUC when compared with platinum-based chemotherapy. However, there was a lack of data on the outcomes of the combination therapy when used outside of clinical trials, and biomarkers associated with benefit from EV/P treatment were also not evaluated thoroughly.

The UNITE study provided data on patients who were treated with EV/P. Tumor mutation burden and genomic alterations from next-generation sequencing were all assessed as biomarkers in patients who had data available to use in the study. A univariate analysis was used to assess the effect of a biomarker on the clinical outcome and a multivariate analysis was used to adjust for other variables. A log-rank test was used to measure progression-free survival (PFS) and overall survival (OS), and objective response rate (ORR) was assessed and compared in patients who had imaging and at least 1 cycle of EV/P. Patients were excluded if they were treated during clinical trials.

Enfortumab vedotin was effective in patients with diabetes mellitus and neuropathy outside of clinical trials | Image credit: Matthieu - stock.adobe.com

There were 118 patients with next-generation sequencing data available, with a median age of 71 years, 74% of the patients being men, and 84% identifying as White. A total of 74% had Eastern Cooperative Oncology Group (ECOG) performance score (PS) of 0/1, 63% had a pure urothelial histology, and 16% had liver metastases. ECOG PS 0/1 was associated with longer PFS and OS for patients. Longer PFS and OS was also associated with albumin of 3.5 mg/dL or higher, neutrophil-to-lymphocyte ratio of 5 or more, and hemoglobin of 10 g/dL or more.

Alterations in KMT2D (HR, 2.2; 95% CI, 1.0-4.5) and TP53 (HR, 2.3; 95% CI, 1.2-4.2) were associated with shorter PFS whereas shorter OS was associated with alterations in TP53 (HR, 2.3; 95% CI, 1.0-5.4). The disease control rate (DCR) was found to be 84% (95% CI, 77%-90%) overall and ORR was 51% (95% CI, 42%-60%).

EV/P was found to have a higher DCR in patients using the combination therapy outside of clinical trials but the ORR was more modest when compared with first-line clinical trials. Inferior outcomes were associated with TP53 and KMT2D alterations.

A second poster 2 built on the first finding by focusing on the efficacy of EV when used in patients with neuropathy and/or diabetes, who are often excluded from the clinical trials assessing its efficacy. EV has been used and approved for aUC both as monotherapy and in the EV/P combination. The poster aimed to assess outcomes for patients with either diabetes, neuropathy, or both when using EV to treat their aUC.

The study also used data from the UNITE multisite retrospective study, which collects data from 17 sites across the US. A logistic regression model was used to evaluate ORR whereas a Kaplan-Meier method and Cox models were used to analyze duration of response (DOR), PFS, and OS. Covariates included liver metastases, number of treatment lines, ECOG PS, body mass index, histology subtype, age, and sex.

There were 666 patients included in the study, of whom 193 had neuropathy, 77 had diabetes, 46 had both, and 343 had neither; there were 7 participants with incomplete data who couldn’t be added to any of these groups. The median age of the cohort was 70 years, 71% were men, and 89% were White. A total of 78% of the participants had an ECOG PS of 0/1 and 13% received EV in the frontline setting.

Significantly lower PFS was found to be associated with baseline neuropathy (HR, 0.81; 95% CI, 0.66-0.98) whereas OS was not significantly different (HR, 0.86; 95% CI, 0.69-1.08). PFS (HR, 1.19; 95% CI, 0.93-1.53) and OS (HR, 1.20; 95% CI, 0.91-1.59) were not associated with baseline diabetes.

The researchers concluded that baseline neuropathy and diabetes should not lead to inferior outcomes for patients using EV. The comorbidities should not affect the use of EV treatment but careful monitoring of toxicities related to neuropathy, diabetes, and EV should be conducted when using EV in these patients.

• Jindal T, Jiang CY, Alhalabi O, et al. Enfortumab vedotin (EV) + pembrolizumab (P) outcomes outside clinical trials and biomarkers of benefit in patients (pts)with advanced urothelial carcinoma: analysis of the UNITE study. Presented at: European Society for Medical Oncology Congress 2024; September 13-17, 2024; Barcelona, Spain. Abstract 1988P.
• Jang A, Jindal T, Jiang CY, et al. Efficacy of enfortumab vedotin (EV) in patients (pts) with (w) advanced urothelial carcinoma (aUC) who have baseline neuropathy (N) and/or diabetes mellitus (DM): a UNITE study analysis. Presented at: European Society for Medical Oncology Congress 2024; September 13-17, 2024; Barcelona, Spain. Abstract 1989P.

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FDA Issues Draft Guidance on Conducting Multiregional Clinical Trials in Oncology

FDA News Release

Today, the U.S. Food and Drug Administration issued a draft guidance for industry that, when finalized, will provide sponsors with recommendations for conducting multiregional clinical trials (MRCT) in support of applications for drugs intended to treat cancer. An MRCT is a trial that is conducted in more than one region under a single protocol, with region defined as a geographical region, country, or regulatory region.

“The FDA encourages sponsors to pursue multiregional clinical trials, but stresses that such trials should be conducted within the appropriate context,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research. “It is important that data from multiregional clinical trials are applicable to patients in the United States who may use the drug and our current standards of oncological care. The new draft guidance, when finalized, will not only support the agency’s review of data generated from multiregional clinical trials, but also help sponsors improve the generalizability and applicability of results from these trials to the U.S. population and to U.S. medical practice.”

There have been decreasing proportions of U.S. participants included in oncology MRCTs. This may limit the ability to determine if an observed treatment outcome in the study is consistent between U.S. enrolled participants and the overall study population in the MRCT. For example, known differences in the prevalence, presentation, causes, or severity of a cancer may exist across countries or regions. These differences can impact how the data can be interpreted in the context of the U.S. population and U.S. medical practice. In addition, the distribution of demographic or clinical characteristics of participants enrolled in these trials may differ significantly from the U.S. population such that foreign clinical data may not be appropriate to support an FDA regulatory decision.

The new draft guidance, “ Considerations for Generating Clinical Evidence from Oncology Multiregional Clinical Development Programs ,” expands on current principles for MRCTs and, when finalized, will provide additional recommendations to improve the planning, design, conduct and analysis of future oncology MRCTs. It also will aid sponsors in planning multiregional clinical development programs that consider the agency’s evaluation of trial results that can be applied to the intended use population in the U.S., and to U.S. standard oncological care.

Comments on the draft guidance must be submitted within 60 days after publication in the Federal Register to Regulations.gov to ensure the agency considers them.

Related Information

• Considerations for Generating Clinical Evidence from Oncology Multiregional Clinical Development Programs

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• DOI: 10.1038/nrclinonc.2017.186
• Corpus ID: 3357929

The evidence framework for precision cancer medicine

• J. Moscow , T. Fojo , R. Schilsky
• Published in Nature Reviews Clinical… 1 March 2018

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Telehealth vs In-Person Early Palliative Care for Patients With Advanced Lung Cancer : A Multisite Randomized Clinical Trial

• 1 Department of Psychiatry, Massachusetts General Hospital, Boston
• 2 Harvard Medical School, Boston, Massachusetts
• 3 Department of Medicine, Massachusetts General Hospital, Boston
• 4 Division of Vascular Neurology and Department of Biomedical Informatics and Data Science, Yale School of Medicine, New Haven, Connecticut
• 5 Department of Oncology, Johns Hopkins University School of Medicine, Baltimore, Maryland
• 6 Department of Psychosocial Oncology and Palliative Medicine, Dana-Farber Cancer Institute, Boston, Massachusetts
• 7 Division of General Internal Medicine and Primary Care, Department of Medicine, Brigham and Women’s Hospital, Boston, Massachusetts
• 8 Department of Oncology and Mayo Clinic Comprehensive Cancer Center, Mayo Clinic, Rochester, Minnesota
• 9 Department of Medicine, Division of General Internal Medicine, University of Colorado School of Medicine, Aurora
• 10 Department of Medicine, University of Wisconsin–Madison, Madison
• 11 Department of Medicine, University of California San Francisco, San Francisco
• 12 Department of Supportive Care Medicine, City of Hope, Duarte, California
• 13 Division of Geriatric Medicine, Palliative Care and Hospice Program, University of North Carolina at Chapel Hill
• 14 Division of General Internal Medicine and Public Health, Section of Palliative Care, Vanderbilt University Medical Center, Nashville, Tennessee
• 15 Division of Geriatric and Palliative Medicine, University of Michigan, Ann Arbor
• 16 Geriatrics Research Education and Clinical Center, Lieutenant Colonel Charles S. Kettles VA Medical Center, Ann Arbor, Michigan
• 17 Department of Palliative and Supportive Care, Cleveland Clinic, Taussig Cancer Institute, Cleveland, Ohio
• 18 School of Nursing and Center for Palliative and Supportive Care, University of Alabama at Birmingham
• 19 Department of Hematology/Oncology, Fox Chase Cancer Center, Philadelphia, Pennsylvania
• 20 Obstetrics and Gynecology and Palliative Medicine, University of Kansas School of Medicine, Kansas City
• 21 Department of Internal Medicine, Atrium Health Wake Forest Baptist, Winston-Salem, North Carolina
• 22 Department of General Medicine, Hospice and Palliative Medicine, University of Virgina School of Medicine, Charlottesville
• 23 Division of Palliative Medicine, Department of Family and Preventive Medicine, Emory University, Emory School of Medicine, Atlanta, Georgia
• 24 Department of Internal Medicine, Rush University Medical Center, Chicago, Illinois
• 25 Division of Hospital Medicine, Section of Palliative Care, Department of Medicine, Northwestern Medicine, Feinberg School of Medicine, Chicago, Illinois
• 26 Department of Internal Medicine and Harold C. Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center, Dallas
• 27 Department of Medicine, Dartmouth-Hitchcock Health, Lebanon, New Hampshire
• Editorial Improving Palliative Care Access for Patients With Cancer Eduardo Bruera, MD JAMA
• Original Investigation Stepped Palliative Care for Patients With Advanced Lung Cancer Jennifer S. Temel, MD; Vicki A. Jackson, MPH, MD; Areej El-Jawahri, MD; Simone P. Rinaldi, MSN, ANP-BC, ACHPN; Laura A. Petrillo, MD; Pallavi Kumar, MD; Kathryn A. McGrath, MD; Thomas W. LeBlanc, MD; Arif H. Kamal, MD; Christopher A. Jones, MD; Dustin J. Rabideau, PhD; Nora Horick, MS; Kedie Pintro, MS; Emily R. Gallagher Medeiros, RN; Kathryn E. Post, PhD, RN, ANP-BC; Joseph A. Greer, PhD JAMA
• Viewpoint Is Medical Assistance in Dying Part of Palliative Care? Harvey Max Chochinov, MD, PhD; Joseph J. Fins, MD JAMA

Question   Does early palliative care delivered via secure video vs in person have an equivalent effect on quality of life in patients with advanced lung cancer?

Findings   In this randomized comparative effectiveness trial of 1250 adults with advanced lung cancer receiving care across 22 institutions in the US, patients assigned to receive early palliative care via video visits reported quality-of-life scores at week 24 that were equivalent to those assigned to in-person palliative care.

Meaning   Findings underscore the potential to increase access to evidence-based early palliative care through telehealth delivery.

Importance   Numerous studies show that early palliative care improves quality of life and other key outcomes in patients with advanced cancer and their caregivers, although most lack access to this evidence-based model of care.

Objective   To evaluate whether delivering early palliative care via secure video vs in-person visits has an equivalent effect on quality of life in patients with advanced non–small cell lung cancer (NSCLC).

Design, Setting, and Participants   Randomized, multisite, comparative effectiveness trial from June 14, 2018, to May 4, 2023, at 22 US cancer centers among 1250 patients within 12 weeks of diagnosis of advanced NSCLC and 548 caregivers.

Intervention   Participants were randomized to meet with a specialty-trained palliative care clinician every 4 weeks either via video visit or in person in the outpatient clinic from the time of enrollment and throughout the course of disease. The video visit group had an initial in-person visit to establish rapport, followed by subsequent virtual visits.

Main Outcomes and Measures   Equivalence of the effect of video visit vs in-person early palliative care on quality of life at week 24 per the Functional Assessment of Cancer Therapy-Lung questionnaire (equivalence margin of ±4 points; score range: 0-136, with higher scores indicating better quality of life). Participants completed study questionnaires at enrollment and at weeks 12, 24, 36, and 48.

Results   By 24 weeks, participants (mean age, 65.5 years; 54.0% women; 82.7% White) had a mean of 4.7 (video) and 4.9 (in-person) early palliative care encounters. Patient-reported quality-of-life scores were equivalent between groups (video mean, 99.7 vs in-person mean, 97.7; difference, 2.0 [90% CI, 0.1-3.9]; P  = .04 for equivalence). Rate of caregiver participation in visits was lower for video vs in-person early palliative care (36.6% vs 49.7%; P  < .001). Study groups did not differ in caregiver quality of life, patient coping, or patient and caregiver satisfaction with care, mood symptoms, or prognostic perceptions.

Conclusions and Relevance   The delivery of early palliative care virtually vs in person demonstrated equivalent effects on quality of life in patients with advanced NSCLC, underscoring the considerable potential for improving access to this evidence-based care model through telehealth delivery.

Trial Registration   ClinicalTrials.gov Identifier: NCT03375489

• Editorial Improving Palliative Care Access for Patients With Cancer JAMA

Read More About

Greer JA , Temel JS , El-Jawahri A, et al. Telehealth vs In-Person Early Palliative Care for Patients With Advanced Lung Cancer : A Multisite Randomized Clinical Trial . JAMA. Published online September 11, 2024. doi:10.1001/jama.2024.13964

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High-Dose vitamin D3 does not provide benefit for metastatic colorectal cancer

RESEARCH SUMMARY Study Title: SOLARIS (Alliance A021703): A multicenter double-blind phase III randomized clinical trial of vitamin D combined with standard chemotherapy plus bevacizumab in patients with previously untreated metastatic colorectal cancer.

Publication: European Society for Medical Oncology 2024 Abstract LBA26

Dana-Farber Cancer Institute authors : Kimmie Ng, MD, MPH , Nadine McCleary, MD, MPH , Jeffrey A. Meyerhardt, MD, MPH

Summary: A double-blind randomized phase 3 clinical trial led by Dana-Farber Cancer Institute researchers and conducted across several hundred cancer centers in the U.S. tested the addition of high-dose vitamin D3 to standard treatment for patients with untreated metastatic colorectal cancer. More than 450 patients received standard chemotherapy plus bevacizumab and were randomized to high-dose or standard dose vitamin D3. The team observed no additional concerning side-effects or toxicities with the addition of high-dose vitamin D3. However, the addition of high-dose vitamin D3 to standard treatment did not delay the progression of cancer more so than standard-dose vitamin D3, according to the team’s analysis after a median 20-month follow-up. A potential benefit for high-dose vitamin D3 was observed for patients with left-sided disease (i.e., primary tumors that arise in the descending colon, sigmoid colon, or rectum) and requires further investigation. 

Significance: The SOLARIS trial was inspired by previous research suggesting that higher levels of vitamin D in the blood are associated with improved survival for metastatic colorectal cancer and that the addition of high-dose vitamin D3 to standard therapy could potentially improve progression free survival. The SOLARIS results suggest, however, that high-dose vitamin D3 cannot be recommended as a treatment for patients with untreated metastatic colon cancer.

Funding: National Cancer Institute; Pharmavite Contact:  Victoria Warren, [email protected]  

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Combination treatment extends survival in locally advanced bladder cancer

'This is very likely to become the new standard of care'

• Link to: Northwestern Now Story

Media Information

• Embargo date: September 15, 2024 9:30 AM CT
• Release Date: September 11, 2024

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Kristin Samuelson

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Journal: New England Journal of Medicine

• One in three bladder cancers becomes advanced and will require radical treatment, including bladder removal
• First trial to show improved survival by adding immunotherapy to chemotherapy in patients with locally advanced bladder cancer (stage II-III)
• Overall survival in combination-treatment group was 82.2% compared to 75.2% in chemotherapy-only group

CHICAGO --- Immunotherapy administered before and after chemotherapy, along with surgical removal of the bladder, improved survival compared to chemotherapy alone in patients with muscle-invasive bladder cancer, according to results of a recent clinical trial that will be published Sept. 15 in the New England Journal of Medicine.

The findings highlight a new treatment regimen for patients with locally advanced bladder cancer that improves treatment response and survival with minimal side effects, said study co-author Dr. Joshua Meeks , a professor of biochemistry and molecular genetics at Northwestern University Feinberg School of Medicine who led the enrollment and clinical trial at Northwestern Medicine.

“This the first trial that's shown that you can add immunotherapy to chemotherapy and show improved response and a survival benefit,” said Meeks, who also is a Northwestern Medicine physician and a member of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University. “This is very likely to become the new standard of care.”

Bladder cancer is one of the most common cancers worldwide, with an estimated 573,000 new cases and more than 200,000 deaths globally in 2020. Locally advanced bladder cancer, which is more common in older adults and men, is cancer that has grown beyond the inner lining of the bladder and invaded nearby tissues, but it has not yet spread to distant organs (known as metastatic). One in three bladder cancers becomes advanced and will require radical treatment, including bladder removal.

For more than 20 years, the standard of care for advanced bladder cancer (stages II to III) involved chemotherapy followed by radical cystectomy (surgical removal of the bladder and surrounding lymph nodes). However, approximately half of patients experience recurrence within three years after treatment.

“These patients have the most to lose or gain, so that's why we treat them more aggressively,” Meeks said. “What hasn't been clear is if adding immunotherapy to chemotherapy has any benefit. In the metastatic setting, it has not been necessarily as successful.”

In the current clinical trial, more than 1,000 patients with localized bladder cancer at academic medical centers from 22 countries in Europe, Asia, North America, Australia and South America were enrolled.

Participants were randomized to receive durvalumab immunotherapy plus chemotherapy (gemcitabine and cisplatin) every three weeks for four cycles, then radical cystectomy followed by durvalumab every four weeks for eight cycles (combination-treatment group), or neoadjuvant chemotherapy followed by radical cystectomy alone (control group).

After 24 months, follow-up analyses showed that event-free survival (patients did not experience a relapse, progression of the disease, or death during the time measured) and overall survival (length of time from the start of treatment or diagnosis until the patient dies from any cause) was longer in the combination-treatment group compared to patients in the control group who received chemotherapy with radical cystectomy alone.

In the experimental group, event-free survival was 67.8% and overall survival was 82.2%. In the chemotherapy with radical cystectomy group, event-free survival was 59.8% and overall survival was 75.2%. Treatment-related adverse events were also the same in both groups (41%).

“We have a new treatment that has a chance to improve response and survival for patients with muscle-invasive bladder cancer,” Meeks said. “For patients who want to aggressively fight this cancer, we have a new way to do that with a minimal increase in toxicity. Our next steps are to determine which tumors will benefit from the addition of durvalumab and why it is so effective for stage II to III bladder cancer, so we really have more work to do.”

Dr. David VanderWeele , associate professor of medicine (hematology and oncology) at Feinberg, served as the local principal investigator for the NIAGRA at Northwestern Medicine.

This work was supported by AstraZeneca. The study’s corresponding author, Dr. Thomas Powles from Barts Cancer Institute at Queen Mary University of London, will present the findings at the European Society for Medical Oncology’s 2024 Annual Meeting.

Massive Bio Launches Patient Connect to Personalize Access to Cancer Clinical Trials Globally

BARCELONA, Spain--(BUSINESS WIRE)--Massive Bio, a global leader in artificial intelligence (AI) for cancer clinical trial enrollment, has announced the launch of Patient Connect, an innovative and free portal designed to help cancer patients navigate their clinical trial journey across the globe.

Massive Bio Patient Connect empowers patients and simplifies their search for the right clinical trial, in the language of their choice. By providing consented access to their medical records, patients enable an in-depth analysis using Massive Bio’s AI-powered multi-trial matching system, allowing them to identify the best clinical trial options based on their specific diagnosis, biomarkers, treatment history and geographic location. This approach is designed to expand access to treatment possibilities, regardless of financial or geographical constraints. Patients can also download their personalized clinical trial matching reports and share their results with their physicians and loved ones, enabling them to make better informed decisions about their cancer care.

Simply by signing up, Patient Connect now allows over 132,000 patients on-boarded by Massive Bio to access their own personal matching results for nearly 16,000 cancer trials. To date, Massive Bio has successfully matched patients to over 33,000 clinical trial sites, demonstrating the scalability of their cutting-edge AI platform. And, in a recent publication at ASCO 2024, Massive Bio, in collaboration with the Precision Cancer Consortium, showed that their unique multi-trial matching approach results in up to 12-fold increase in patient eligibility for a clinical trial.

Dr. Arturo Loaiza-Bonilla, Chief Medical Officer and Co-Founder of Massive Bio stated that, “Patient Connect redefines how patients engage with clinical trials, offering them a lifeline to new treatment possibilities and hope for better outcomes.”

In addition to technological solutions, Massive Bio offers personalized support through its concierge services. Once referred, Massive Bio’s patient relations coordinators, MDs and oncology nurses work closely with patients to answer their questions, provide guidance, and assist in the final steps of the enrollment process, including referral to a site, resolution of logistical issues, and understanding their financial assistance needs. This ensures a smooth transition from referral to trial participation, addressing any concerns and logistical issues that may arise.

“Patient Connect empowers people to intuitively navigate the clinical trial enrollment process, keeping patients connected to their physicians and loved ones throughout their personal journey,” said Oz Hüner, Chief Product Officer of Massive Bio.

Engaging with oncologists and hematologists is as important as patient engagement. Using Massive Bio Clinical Network, treating physicians are able to review their patient’s pre-screening results and easily start and monitor their patient’s enrollment process. Massive Bio uniquely combines patient and provider engagement to increase clinical trial enrollment globally, a first in the industry.

To learn more about Massive Bio Patient Connect, please visit www.massivebio.com/patient-connect . Physicians interested in Massive Bio Clinical Network may learn more and register by visiting www.massivebio.com/clinical-network .

About Massive Bio:

Massive Bio’s vision is to transform the entire pharmaceutical value chain with disruptive solutions that enhance the ecosystem from drug development to commercialization. As a unique AI-enabled real-world data company, Massive Bio addresses all friction points in the end-to-end patient journey, facilitating patient access to advanced treatment options and optimizing drug clinical trials and commercialization for pharmaceutical companies. Committed to breaking down barriers and enhancing equitable access to clinical trials, Massive Bio fosters value-based oncology decisions and facilitates data-driven cancer treatment. Founded in 2015 by a team of clinical, technology, and M&A executives, Massive Bio has served over four dozen pharmaceutical companies, contract research organizations, and hospital networks. It is a founding member of the CancerX public-private partnership and participates in the Cancer Moonshot White House initiative. Massive Bio has earned recognition from the National Cancer Institute through an SBIR contract. Today, Massive Bio has a global presence with over 100 employees across 17 countries. For further details, please visit our website www.massivebio.com and connect with us on our social media channels.

Media: Massive Bio Mert Turkkan Marketing Director +1 646 461 4946 [email protected]