Immunotherapy + Radiotherapy for Merkel Cell Carcinoma
(iPRRT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment for Merkel cell carcinoma, a rare and aggressive skin cancer. Researchers combine two drugs: pembrolizumab (also known as KEYTRUDA or MK-3475), which helps the immune system attack cancer, and Lutathera, a radioactive drug that targets and kills cancer cells. The study examines the combination's effect on shrinking the cancer or stopping its growth. Candidates for this trial include those whose Merkel cell cancer has worsened despite previous treatments targeting the PD-1 protein. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Do I need to stop my current medications to join the trial?
The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants must have recovered from prior cancer treatments and should not be on certain immunosuppressive therapies. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the FDA has approved pembrolizumab for treating Merkel cell cancer. It has helped some patients by shrinking or eliminating their tumors and is generally well-tolerated by people with this type of cancer. Extensive testing in many patients has provided safety information for pembrolizumab, enhancing understanding of its safety profile.
Lutetium Lu 177 dotatate, also known as Lutathera, is FDA-approved for treating certain neuroendocrine tumors. Although not yet approved for Merkel cell cancer, it has demonstrated effectiveness in shrinking tumors in other types of cancers and has been used safely in those cases.
The combination of pembrolizumab and Lutathera is still under study for Merkel cell cancer. However, since each drug is already used safely for different cancers, there is some confidence in their combined safety. Joining any study carries risks, so discussing these with a healthcare provider is important.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of pembrolizumab and Lutetium Lu177 for Merkel Cell Carcinoma because it offers a novel approach by pairing immunotherapy with targeted radiotherapy. Pembrolizumab is an immunotherapy that boosts the body's immune system to recognize and attack cancer cells, while Lutetium Lu177 dotatate delivers targeted radiation directly to the tumor, sparing healthy tissue. This dual approach is different from the standard chemotherapy and standalone immunotherapy options, potentially offering enhanced effectiveness by attacking cancer on two fronts.
What evidence suggests that the combination of pembrolizumab and Lutathera could be effective for Merkel cell carcinoma?
Research has shown that pembrolizumab, a type of immunotherapy, can help treat Merkel cell carcinoma (MCC) by boosting the immune system to fight cancer, causing some MCC tumors to shrink or disappear. Lutetium Lu 177 dotatate (Lutathera) kills cancer cells and has FDA approval for certain rare tumors originating from hormone-releasing cells. Although not approved for MCC, it has demonstrated potential in reducing these tumors and extending patient survival. Some studies suggest that Lutathera can enhance cancer cells' responsiveness to immunotherapy. In this trial, participants will receive a combination of pembrolizumab and Lutetium Lu 177 dotatate to effectively target MCC.24678
Who Is on the Research Team?
Anna C Pavlick, BSN, MSc, DO, MBA
Principal Investigator
Sandra and Edward Meyer Cancer Center at Weill Cornell Medicine
Are You a Good Fit for This Trial?
Adults with Merkel cell carcinoma who have somatostatin receptors and progressed after anti-PD-1/L1 therapy can join. They must be in good health, understand the study, and use contraception if of childbearing potential. Excluded are those with severe allergies to pembrolizumab, active infections or autoimmune diseases, recent live vaccines, organ transplants, other cancers within 3 years (except certain skin cancers), brain metastases requiring steroids, significant heart disease or HIV.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Safety Run-in
A run-in study to ensure safety and tolerability of the combination of pembrolizumab and lutetium Lu 177 dotatate
Treatment
Participants receive pembrolizumab every 6 weeks and lutetium Lu 177 dotatate every 2 months for 4 doses
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Lutetium Lu 177 dotatate
- Pembrolizumab
Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:
- Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
- Melanoma
- Non-small cell lung cancer (NSCLC)
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Hepatocellular carcinoma
- Renal cell carcinoma
- Cervical cancer
- Endometrial carcinoma
- Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
- Melanoma
- Non-small cell lung cancer (NSCLC)
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Hepatocellular carcinoma
- Renal cell carcinoma
- Cervical cancer
- Endometrial carcinoma
- Untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
Find a Clinic Near You
Who Is Running the Clinical Trial?
Pashtoon M. Kasi
Lead Sponsor
Weill Medical College of Cornell University
Lead Sponsor
GI Research Foundation
Collaborator
Novartis
Industry Sponsor
Vasant Narasimhan
Novartis
Chief Executive Officer since 2018
MD from Harvard Medical School, Bachelor's in Biological Sciences from University of Chicago, Master's in Public Policy from John F. Kennedy School of Government
Shreeram Aradhye
Novartis
Chief Medical Officer since 2022
MD from Yale University, MSc in Clinical Epidemiology from University of Pennsylvania
Merck Sharp & Dohme LLC
Industry Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University