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
- advanced skin cancermetastatic melanoma10040900
- Registration Number
- NL-OMON53805
- Lead Sponsor
- Regeneron Pharmaceuticals Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 7
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. Patients with histologically confirmed unresectable Stage III and Stage IV
(metastatic) melanoma (AJCC, 8th 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 (with the
exclusion of endocrinopathies which are fully controlled by hormone replacement
) 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 10% of the total population.
3. 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
4. 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 <16 years)
5. Anticipated life expectancy of at least 3 months.
Please note other protocol-defined Inclusion criteria apply
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 BRAF-mutated 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 (<=10mg 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 10mg of
prednisone/day or equivalent. Inhaled or topical steroids are permitted,
provided if 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 immuno- therapy,
chemotherapy, radiotherapy, major surgery or biological therapy within 3 weeks
prior to the first dose of trial treatment. Adjuvant hormonotherapy used for
breast cancer or other hormone-sensitive cancers in long term remission is
allowed.
Other comorbidities:
7. 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.
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 (>10mg 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
Other protocol-defined Exclusion criteria apply
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>From protocol amendment 1 16Feb2022, Clinical Study Protocol Synopsis, page 25<br /><br><br /><br>The primary endpoint is:<br /><br>• PFS (progression-free survival) (per Response Evaluation Criteria in Solid<br /><br>Tumors (RECIST) 1.1 based on blinded independent central review [BICR]).</p><br>
- Secondary Outcome Measures
Name Time Method