A PHASE 3 TRIAL OF FIANLIMAB (REGN3767, ANTI-LAG-3) + CEMIPLIMAB VERSUS PEMBROLIZUMAB IN PATIENTS WITH PREVIOUSLY UNTREATED UNRESECTABLE LOCALLY ADVANCED OR METASTATIC MELANOMA.
- Conditions
- C43 Malignant melanoma of skinMalignant melanoma of skin
- Registration Number
- PER-051-22
- Lead Sponsor
- REGENERON PHARMACEUTICALS, INC.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- In enrollment
- Sex
- All
- Target Recruitment
- 13
Inclusion:
1. Age =12 years on the date of providing informed consent. Note: Patients who are <18 years will be included in the territories, where accepted, per local laws and regulations. In Canada, Italy, Turkey, Poland and South Africa, patients <18 will not be enrolled.
2. A patient must have a valid LAG-3 immunohistochemistry (IHC) result, as determined by central testing, to be enrolled into the study. Any LAG-3 level (0-100% expression) will be allowed.
3. Patients with histologically confirmed unresectable Stage III and Stage IV (metastatic) melanoma (AJCC, eighth revised edition) who have not received prior systemic therapy for advanced unresectable disease.
a. Patients who received adjuvant and/or neoadjuvant systemic therapies are eligible if they did not have evidence of progression or recurrence of disease and/or discontinued due to occurrence of unmanageable irAEs = grade 3 while on such therapies. Also, patients must have had a treatment-free and disease-free interval of >6 months.
b. Patients with acral and mucosal melanomas are eligible. Accrual will be limited to approximately 10% of the total population.
4. Measurable disease per RECIST v1.1
a. Previously irradiated lesions can only be counted as target lesions if they have been demonstrated to progress and no other target lesion is available
b. Cutaneous lesions should be evaluated as non-target lesions.
5. Performance status:
a) For adult patients: Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.
b) For pediatric patients: Karnofsky performance status =70 (patients =16 years) or Lansky performance status =70 (patients
For pediatric patients: Karnofsky performance status =70 (patients =16 years) or Lansky performance status =70 (patients <16 years)
6. Anticipated life expectancy of at least 3 months.
Exclusion:
Medical conditions:
1. Uveal melanoma
2. 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.
3. 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.
4. Unknown BRAF V600 mutation status. Patients with BRAFmutated melanoma who present with symptoms of rapidly progressive disease and are considered by Investigator’s assessment as likely to benefit from upfront treatment with BRAF/MEK-inhibitors should not be enrolled in the study.
Prior/concomitant therapy:
5. Systemic immune suppression:
a. Use of immunosuppressive doses of corticosteroids (=10 mg of prednisone per day or equivalent) within 14 days of the first dose of study medication. Physiologic replacement doses are allowed up to and including 10 mg of prednisone/day or equivalent. Inhaled or topical steroids are permitted, provided that they are not for treatment of an autoimmune disorder.
b. Other clinically relevant forms of systemic immune suppression.
6. Treatment with other anti-cancer therapy including immunotherapy, chemotherapy, major surgery or biological therapy within 21 days prior to the first dose of trial treatment. Adjuvant hormonotherapy used for breast cancer or other hormonesensitive cancers in long term remission is allowed.
Other comorbidities:
7. History or current evidence of significant (CTCAE grade =2) local or systemic infection (eg, cellulitis, pneumonia, septicemia) requiring systemic antibiotic treatment within 14 days prior to the first dose of trial medication.
8. Active or untreated brain metastases or spinal cord compression. Patients with leptomeningeal disease are excluded. Patients with known brain metastases are eligible if they:
a. received radiotherapy or another appropriate standard therapy for the brain metastases,
b. have neurologically returned to baseline (except for residual signs and symptoms related to the CNS treatment) for at least 14 days prior to enrollment.
c. did not require immunosuppressive doses of corticosteroids therapy (>10 mg of prednisone per day or equivalent) in the 14 days prior to enrollment. Note: Patients with asymptomatic, single untreated brain metastasis < 10 mm in size are eligible.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response Evaluation Criteria<br>in Solid Tumors (RECIST) 1.1 based on blinded independent<br>central review [BICR]<br> NAME OF THE RESULT: 1. PFS (progression-free survival) defined by Response Evaluation Criteria<br>in Solid Tumors (RECIST) 1.1 based on blinded independent<br>central review [BICR]).<br> PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE<br> PRIMARY RESULT: Throughout the study
- Secondary Outcome Measures
Name Time Method