Nivolumab + Ipilimumab +/- SBRT for Skin Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the effectiveness of combining two drugs, nivolumab (Opdivo) and ipilimumab (Yervoy), for treating Merkel cell carcinoma, a type of skin cancer. Researchers aim to determine if adding stereotactic body radiation therapy (SBRT) enhances the treatment's effectiveness. Participants will receive either the drug combination alone or with SBRT to assess which approach better combats the cancer. The trial seeks individuals with active Merkel cell carcinoma that cannot be surgically removed or has recurred, particularly those with at least two measurable cancer areas. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop your current medications, but you cannot be on systemic corticosteroids or other immunosuppressive medications within 14 days of joining. Inhaled or topical steroids are allowed if you don't have an active autoimmune disease.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the combination of nivolumab and ipilimumab is generally well-tolerated in people with advanced melanoma, a type of skin cancer. The FDA has approved this treatment. In one study, 16% of patients developed a rash, while more serious rashes affected about 3.5% of patients. When stereotactic body radiation therapy (SBRT) was added, all patients experienced some side effects. More severe side effects, known as grade 3 or 4, occurred in about 70.4% of patients. While these treatments have proven effective, considering these side effects is important when deciding whether to join a trial.12345
Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments because they combine powerful immunotherapy drugs, Nivolumab and Ipilimumab, with or without a precise form of radiation called Stereotactic Body Radiation Therapy (SBRT). Unlike traditional treatments for skin cancer, which often involve surgery or chemotherapy, these drugs work by boosting the body's immune system to attack cancer cells more effectively. The addition of SBRT in one of the treatment arms is particularly interesting because it delivers high doses of radiation to tumors with extreme precision, potentially enhancing the immune response triggered by the drugs. This innovative approach could lead to more effective and less invasive treatment options for skin cancer patients.
What evidence suggests that this trial's treatments could be effective for skin cancer?
Research shows that using nivolumab and ipilimumab together effectively treats advanced melanoma, a type of skin cancer. Studies indicate that 52% of patients receiving both drugs survive for at least five years, outperforming the use of either drug alone. More patients also experienced tumor shrinkage with the combination than with ipilimumab alone. In this trial, participants in Arm A will receive the combination of nivolumab and ipilimumab. Meanwhile, Arm B will study the combination of nivolumab, ipilimumab, and stereotactic body radiation therapy (SBRT). Early reports suggest that adding SBRT might further improve survival rates for patients with metastatic melanoma. This combination is being studied for its potential to boost the body's immune response against cancer cells.12356
Who Is on the Research Team?
Evan Wuthrick, M.D
Principal Investigator
H. Lee Moffitt Cancer Center and Research Institute
Are You a Good Fit for This Trial?
This trial is for adults with Merkel Cell Carcinoma that's measurable, not removed by surgery or at stage IV. They should be fairly active (ECOG <2), have two distinct lesions, and can have had prior treatments if there's still measurable disease. Excluded are those with brain metastasis, autoimmune diseases, recent immunosuppressants use, or certain cancer histories.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Nivolumab every 2 weeks and Ipilimumab every 6 weeks, with or without Stereotactic Body Radiation Therapy (SBRT) at the start of week 2
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Ipilimumab
- Nivolumab
- Stereotactic Body Radiation Therapy (SBRT)
Ipilimumab is already approved in United States, European Union for the following indications:
- Advanced melanoma
- Stage III unresectable melanoma
- Stage IV metastatic melanoma
- Advanced melanoma
- Stage III unresectable melanoma
- Stage IV metastatic melanoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
H. Lee Moffitt Cancer Center and Research Institute
Lead Sponsor
Bristol-Myers Squibb
Industry Sponsor
Christopher Boerner
Bristol-Myers Squibb
Chief Executive Officer since 2023
PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis
Deepak L. Bhatt
Bristol-Myers Squibb
Chief Medical Officer since 2024
MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania