IMM60 + Pembrolizumab for Melanoma
Trial Summary
What is the purpose of this trial?
This trial is testing a new drug, IMM60, alone and with pembrolizumab in patients with advanced melanoma or non-small cell lung cancer. The goal is to see if this combination can improve survival by helping the immune system fight cancer more effectively.
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the drug Pembrolizumab for treating melanoma?
Pembrolizumab has been shown to improve survival and response rates in patients with advanced melanoma, as demonstrated in several clinical trials. It is effective in patients who have not responded to other treatments, like ipilimumab and BRAF/MEK inhibitors, and has an acceptable safety profile.12345
Is the combination of IMM60 and Pembrolizumab safe for humans?
Pembrolizumab, also known as KEYTRUDA, has been shown to be generally safe in humans, with common side effects including tiredness, rash, itching, and diarrhea. Some less common but serious side effects involve the immune system, such as inflammation of the lungs (pneumonitis), liver (hepatitis), or thyroid issues.16789
What makes the drug IMM60 + Pembrolizumab unique for treating melanoma?
The combination of IMM60 and Pembrolizumab is unique because it pairs a novel treatment (IMM60) with Pembrolizumab, a drug that blocks a protein called PD-1 on immune cells, helping them attack cancer cells more effectively. This combination aims to enhance the immune response against melanoma, potentially offering a new option for patients who have not responded to other treatments.124510
Eligibility Criteria
This trial is for adults with advanced melanoma or stage IV non-small cell lung cancer (NSCLC) who are in good physical condition, have at least one measurable lesion, and proper organ function. NSCLC patients must not have certain gene mutations and need a PD-L1 assessment. Melanoma patients require known BRAF mutation status. Participants must agree to contraception use.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Phase 1: Dose Finding
Initial safety assessment and dose finding for IMM60 alone and in combination with pembrolizumab
Phase 2: Randomized Treatment
Participants receive IMM60 + pembrolizumab or pembrolizumab alone to assess progression-free survival
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- IMM60
- Pembrolizumab
Find a Clinic Near You
Who Is Running the Clinical Trial?
iOx Therapeutics
Lead Sponsor
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