Trial Title:
A Trial to Learn if Fianlimab and Cemiplimab Are Safe and Work Better Than Anti-PD1 Alone in Adult Participants With Resectable Stage 3 or 4 Melanoma
NCT ID:
NCT06190951
Condition:
Melanoma
Conditions: Official terms:
Melanoma
Pembrolizumab
Cemiplimab
Conditions: Keywords:
Skin cancer
Fully resectable stage III melanoma
Fully resectable stage IV melanoma
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
pembrolizumab
Description:
Administered intravenous (IV) every 3 weeks (Q3W) Phase 3 active comparator
Arm group label:
pembrolizumab
Other name:
MK-3475
Other name:
lambrolizumab
Other name:
Keytruda
Other name:
Anti-PD1
Intervention type:
Drug
Intervention name:
fianlimab
Description:
Administered IV Q3W Phase 2
Arm group label:
cemiplimab+fianlimab HD
Arm group label:
cemiplimab+fianlimab LD
Other name:
REGN3767
Intervention type:
Drug
Intervention name:
cemiplimab
Description:
Administered IV Q3W Phase 2 Active Comparator
Arm group label:
cemiplimab
Other name:
REGN2810
Other name:
Libtayo
Intervention type:
Drug
Intervention name:
cemiplimab+fianlimab
Description:
Administered IV Q3W Phase 3 Either fianlimab HD or fianlimab LD in combination with
cemiplimab will be chosen for Phase 3
Arm group label:
cemiplimab+fianlimab HD
Arm group label:
cemiplimab+fianlimab LD
Other name:
REGN2810
Other name:
Libtayo
Other name:
REGN3767
Summary:
This study is researching an experimental drug called REGN3767, also known as fianlimab
(R3767), when combined with another medication called cemiplimab (each individually
called a "study drug" or called "study drugs" when combined) compared with an approved
medication called pembrolizumab. These types of study drugs are collectively known as
immune checkpoint inhibitors. The study is focused on participants with a type of skin
cancer known as melanoma.
The objective of this study is to see if the combination of fianlimab and cemiplimab is
an effective treatment compared to pembrolizumab as peri-operative therapy in
participants with high-risk melanoma.
The study is looking at several other research questions, including:
- What side effects may happen from receiving the study drug(s).
- How much study drug(s) is in the blood at different times.
- Whether the body makes antibodies against the study drug(s) (which could make the
drug less effective or could lead to side effects). Antibodies are proteins that are
naturally found in the blood stream that fight infections.
- How administering the study drugs might improve quality of life.
Criteria for eligibility:
Criteria:
Key Inclusion Criteria:
1. 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.
2. 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.
3. 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.
4. 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).
5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
Key Exclusion Criteria:
Medical conditions:
1. Primary 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. 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.
4. 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:
5. 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.
6. 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:
7. Participants with a history of myocarditis.
8. 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
USC Norris Comprehensive Cancer Center
Address:
City:
Los Angeles
Zip:
90033
Country:
United States
Status:
Recruiting
Facility:
Name:
UCSF
Address:
City:
San Francisco
Zip:
94143
Country:
United States
Status:
Recruiting
Facility:
Name:
St John's Cancer Institute
Address:
City:
Santa Monica
Zip:
90404
Country:
United States
Status:
Recruiting
Facility:
Name:
Hartford Hospital
Address:
City:
Hartford
Zip:
06102
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Massachusetts Chan Medical School
Address:
City:
Worcester
Zip:
01655
Country:
United States
Status:
Recruiting
Facility:
Name:
Rutgers Cancer Institute of New Jersey
Address:
City:
New Brunswick
Zip:
08901
Country:
United States
Status:
Recruiting
Facility:
Name:
Seidman Cancer Center
Address:
City:
Cleveland
Zip:
44106
Country:
United States
Status:
Recruiting
Facility:
Name:
Cleveland Clinic Foundation
Address:
City:
Cleveland
Zip:
44195
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Tennessee Medical Center
Address:
City:
Knoxville
Zip:
37920
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Virginia
Address:
City:
Charlottesville
Zip:
22908
Country:
United States
Status:
Recruiting
Start date:
September 18, 2024
Completion date:
June 4, 2033
Lead sponsor:
Agency:
Regeneron Pharmaceuticals
Agency class:
Industry
Source:
Regeneron Pharmaceuticals
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06190951
