Alintegimod + Ipilimumab + Nivolumab for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This study is an open-label Phase Ib (Part A) dose escalation followed by a blinded, randomized, multi cohort Phase 2a (Part B) comparison of combination vs. reference regimens.Currently study will only be enrolling the Phase 1b and the Phase 2a protocol requirements will be added to the study near completion of the Phase 1b
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications. However, you should avoid medications that strongly affect liver enzymes (CYP3A) within 2 weeks before starting the trial. It's best to discuss your current medications with the trial team.
What is known about the safety of Alintegimod, Ipilimumab, and Nivolumab in humans?
Ipilimumab and Nivolumab, when used together or separately, can cause immune-related side effects like diarrhea, liver inflammation, lung inflammation, kidney issues, and heart problems. These side effects can be serious, and in some cases, have led to emergency room visits or hospital admissions. It's important for these side effects to be managed properly to prevent serious health issues.12345
What makes the drug combination of Alintegimod, Ipilimumab, and Nivolumab unique for cancer treatment?
The combination of Alintegimod, Ipilimumab, and Nivolumab is unique because it combines different mechanisms of action to enhance the immune system's ability to fight cancer. Ipilimumab and Nivolumab are known to work together effectively in other cancers by blocking proteins that prevent the immune system from attacking cancer cells, potentially offering a novel approach compared to standard chemotherapy.678910
What data supports the effectiveness of the drug combination Alintegimod, Ipilimumab, and Nivolumab for cancer?
Who Is on the Research Team?
Lionel Lewis, MA, MB.Bch, MD
Principal Investigator
7 Hills Pharma
Are You a Good Fit for This Trial?
This trial is for adults with various advanced cancers, including skin, kidney, liver cancer, and more. Participants must have a specific genetic feature (like Lynch Syndrome) or high levels of certain proteins. Pregnant women and those with autoimmune diseases or other conditions that could interfere with the study are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation - Open Label Phase 1b
Alintegimod dose escalation with 3 cohorts, followed by Alintegimod monotherapy for 1 cycle, Alintegimod + Ipilimumab for 4 cycles, and Nivolumab for 11 cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Alintegimod
- Ipilimumab
- Nivolumab
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?
7 Hills Pharma, LLC
Lead Sponsor