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Monoclonal Antibodies
Fianlimab + Cemiplimab for Melanoma
Phase 2 & 3
Recruiting
Research Sponsored by Regeneron Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with histologically confirmed unresectable Stage III and Stage IV (metastatic) melanoma who have not received prior systemic therapy for advanced unresectable disease
Age ≥12 years on the date of providing informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 years
Awards & highlights
Study Summary
This trial is testing whether a combination of two drugs is better than one drug at treating cancer. The study will also look at the side effects of the drugs and how well they work in children.
Who is the study for?
Adolescents and adults with advanced melanoma that hasn't spread too much can join this trial. They should be over 12 years old, have a life expectancy of at least 3 months, and not have had previous systemic treatments for their condition. People with certain types of melanoma or those who are immunocompromised can't participate.Check my eligibility
What is being tested?
The study is testing if combining two drugs, Fianlimab and Cemiplimab, works better than Pembrolizumab alone in stopping the cancer from progressing. It also looks at overall survival rates, response to treatment, safety in young people (12-18), quality of life impacts, and how the body processes the drugs.See study design
What are the potential side effects?
Possible side effects include immune system reactions that could affect organs or cause infections; infusion-related reactions; fatigue; skin issues like rash; hormonal imbalances requiring hormone therapy; digestive problems such as diarrhea or liver inflammation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have advanced melanoma that cannot be surgically removed and haven't received systemic therapy for it.
Select...
I am 12 years old or older.
Select...
I am mostly active and can carry out daily activities without significant assistance.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective response rate (ORR)
Progression-free survival (PFS)
Secondary outcome measures
Change in GHS/QoL per EORTC QLQ-C30
Change in global health status/quality of life (GHS/QoL) per EORTC QLQ-C30
Change in physical functioning per EORTC QLQ-C30
+23 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Pneumothorax
5%
Malnutrition, Hypercalcemia and Weakness
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
4Treatment groups
Experimental Treatment
Group I: C: cemiplimab+placeboExperimental Treatment2 Interventions
Phase 2 (as described in the protocol)
Group II: B: pembrolizumab+placeboExperimental Treatment2 Interventions
Phase 2 and Phase 3
Group III: A: fianlimab+cemiplimab dose 1Experimental Treatment2 Interventions
Phase 2 and Phase 3
Group IV: A1: fianlimab+cemiplimab dose 2Experimental Treatment2 Interventions
Phase 2 and Phase 3 (except for PA1 patients as described in the protocol)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Cemiplimab
2015
Completed Phase 3
~1340
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
Regeneron PharmaceuticalsLead Sponsor
625 Previous Clinical Trials
379,873 Total Patients Enrolled
14 Trials studying Melanoma
3,415 Patients Enrolled for Melanoma
Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals
265 Previous Clinical Trials
250,415 Total Patients Enrolled
8 Trials studying Melanoma
2,910 Patients Enrolled for Melanoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My previously treated cancer spots can only be tracked if they've grown and there are no other spots to track.I had cancer treatment without worsening for 6+ months and stopped only if side effects were too severe, except fully treated hormone issues.I have been diagnosed with uveal melanoma.I don't know my cancer's BRAF V600 mutation status.I have acral or mucosal melanoma.I have an autoimmune disease treated with immunosuppressants in the last 2 years, except for vitiligo, resolved childhood asthma, hypothyroidism needing only hormone replacement, or psoriasis not needing systemic treatment.I have advanced melanoma that cannot be surgically removed and haven't received systemic therapy for it.I have treated brain metastases and am not on high-dose steroids.I am 12 years old or older.I do not have an uncontrolled HIV, HBV, or HCV infection or a related immunodeficiency.I am mostly active and can carry out daily activities without significant assistance.
Research Study Groups:
This trial has the following groups:- Group 1: A: fianlimab+cemiplimab dose 1
- Group 2: A1: fianlimab+cemiplimab dose 2
- Group 3: B: pembrolizumab+placebo
- Group 4: C: cemiplimab+placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many people will be included in this test?
"In order to run this study, 1,590 patients that meet the requirements need to be enrolled. The sponsor, Regeneron Pharmaceuticals, will administer the trial from different locations including The Angeles Clinic and Research Institute in Los Angeles, California and University of Tennessee Medical Center in Knoxville, Tennessee."
Answered by AI
What is the mortality rate for patients who take Pembrolizumab?
"Pembrolizumab has been studied in multiple Phase 3 trials, so its safety is well-documented and it received a score of 3."
Answered by AI
Are investigators still looking for new volunteers for this experiment?
"The latest information from clinicaltrials.gov is that this study is still recruiting participants. The trial was originally posted on July 14th, 2020 and updated November 4th, 2020."
Answered by AI
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