Trial purpose
Cancer treatment
Tumor type
Skin
Age
18+
Clinical summary
Summary
This clinical trial is researching an experimental drug called REGN3767, also known as fianlimab, when combined with another medication called cemiplimab, compared with an approved medication called pembrolizumab. These types of drugs are known as immune checkpoint inhibitors and are a type of immunotherapy.
The study aims to determine if using the combination of two immunotherapy drugs, fianlimab and cemiplimab, is more effective than the standard treatment, pembrolizumab, when given as peri-operative therapy (before and/or after surgery) for people with high-risk melanoma.
Eligible participants will be randomly assigned to one of four treatment arms:
- Experimental: cemiplimab+fianlimab high dose, given intravenously every 3 weeks
- Experimental: cemiplimab+fianlimab low dose, given intravenously every 3 weeks
- Active Comparator Phase 2: cemiplimab alone, given intravenously every 3 weeks
- Active Comparator Phase 3: pembrolizumab alone, given intavenously every 3 weeks
Conditions
This trial is treating people with stage III or stage IV melanoma that is able to be removed in surgery (resectable)
Eligibility
Inclusion
- All patients must be either stage III (IIIB, IIIC, IIID) or stage IV (M1a, M1b, M1c) per American Joint Committee on Cancer (AJCC) 8th edition (Amin 2017) and have histologically confirmed cutaneous melanoma that is deemed completely surgically resectable in order to be eligible as described in the protocol.
- Patients with stage III melanoma must have clinically detectable disease that is confirmed as malignant on the pathology report. The pathology report must be reviewed, signed and dated by the investigator; this process will be confirmed during the interactive voice response system (IVRS) process as described in the protocol.
- Patients must be candidates for full resection with curative intent and must be able to be surgically rendered free of disease with negative margins on resected specimens at surgery. The treatment plan including date of surgery must be documented by the investigator prior to randomization.
- All patients must undergo full disease staging through a complete physical examination and imaging studies within 4 weeks prior to randomization. Imaging must include a computer tomography (CT) scan of the chest, abdomen, pelvis (if the primary tumor is on the head/neck then include a CT scan of head/neck), and all known sites of previously resected disease (if applicable) and brain magnetic resonance imaging (MRI) (or brain CT with contrast allowed if MRI is contraindicated).
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
Exclusion
Medical conditions:
- Primary uveal melanoma
- Ongoing or recent (within 2 years) evidence of an autoimmune disease that required systemic treatment with immunosuppressive agents. The following are non-exclusionary: vitiligo, childhood asthma that has resolved, residual hypothyroidism that requires only hormone replacement, psoriasis not requiring systemic treatment.
- Patients must not have received any prior systemic anti-cancer therapy for melanoma. Prior radiotherapy for melanoma is allowed if not given to a target lesion or, if given to a target lesion, there is pathological evidence of disease progression in the same lesion.
-
Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C virus (HCV) infection; or diagnosis of immunodeficiency that is related to or results in chronic infection as described in the protocol.
Prior/concomitant therapy:
- Use of immunosuppressive doses of corticosteroids (>=10mg of prednisone per day or equivalent) within 14 days of the first dose of study medication as described in the protocol.
-
Treatment with any anti-cancer therapy for malignancies other than melanoma, including immuno- therapy, chemotherapy, radiotherapy, or biological therapy in the 5 years prior to randomization as described in the protocol.
Other comorbidities:
- Participants with a history of myocarditis.
- History or current evidence of significant (CTCAE grade ≥2) local or systemic infection (e. g., cellulitis, pneumonia, septicemia) requiring systemic antibiotic treatment within 2 weeks prior to the first dose of trial medication.
Note: Other protocol-defined inclusion/ exclusion criteria apply
Inclusion
- You have been diagnosed with cancer, but have not received any treatment.
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Regeneron Pharmaceuticals
Scientific Title
A Phase 2 and Phase 3 Peri-operative Trial of Fianlimab and Cemiplimab Compared With Anti-PD1 Alone in Patients With Resectable Stage III and IV Melanoma
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