NCT03599713CompletedPhase 2
A Phase 2 Study of INCMGA00012 in Participants With Metastatic Merkel Cell Carcinoma (POD1UM-201)
Incyte Corporation65 sites in 8 countries107 target enrollmentStarted: February 25, 2019Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Incyte Corporation
- Enrollment
- 107
- Locations
- 65
- Primary Endpoint
- Objective Response Rate (ORR)
Study Overview
Brief Summary
The purpose of this study is to assess the clinical activity and safety of INCMGA00012 in participants with advanced/metastatic Merkel cell carcinoma (MCC).
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Signed informed consent.
- •Diagnosis of MCC with distant metastatic disease or recurrent, advanced locoregional disease not amenable to surgery or radiation
- •Eastern Cooperative Oncology Group performance status of 0 to
- •Measurable disease according to RECIST v1.
- •Availability of tumor tissue (fresh or archival) for central pathology review.
- •Willingness to avoid pregnancy or fathering children based on protocol-defined criteria.
Exclusion Criteria
- •Prior systemic therapy for MCC, including chemotherapy and prior PD-1 or PD-L1-directed therapy.
- •Treatment with anticancer drugs or participation in another interventional clinical study within 21 days before the first administration of study drug.
- •Has not recovered to ≤ Grade 1 or baseline from toxic effects of prior therapy (with the exceptions for anemia not requiring transfusion support and any grade of alopecia) and/or complications from prior surgical intervention within 7 days before starting study treatment.
- •Radiation therapy administered within 2 weeks of first dose of study treatment or radiation therapy to the thoracic region that is > 30 Gy within 6 months of the first dose of study treatment.
- •Known central nervous system (CNS) metastases and/or carcinomatous meningitis.
- •History of second malignancy within 3 years (with exceptions).
- •Laboratory values outside the protocol-defined range at screening.
- •Clinically significant pulmonary, cardiac, gastrointestinal or autoimmune disorders.
- •Active bacterial, fungal, or viral infections, including hepatitis A, B, and C.
- •Receipt of a live vaccine within 28 days of planned start of study therapy.
- •Current use of protocol-defined prohibited medication.
- •Known hypersensitivity to another monoclonal antibody that cannot be controlled with standard measures (eg, antihistamines and corticosteroids).
- •Inability or unlikely, in the opinion of the investigator, to comply with the Protocol requirements.
- •Participant who is pregnant or breastfeeding.
Arms & Interventions
Retifanlimab: Chemotherapy: Naïve
Experimental
Intervention: Retifanlimab (Drug)
Retifanlimab: Chemotherapy: Refractory
Experimental
Intervention: Retifanlimab (Drug)
Outcomes
Primary Outcomes
Objective Response Rate (ORR)
Time Frame: up to 26.8 months
ORR was defined as the percentage of participants with a confirmed overall response of complete response (CR) or partial response (PR), per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1), as determined by Independent Central Radiographic Review (ICR), at any post-Baseline visit until the first progressive disease (PD) or new anti-cancer therapy. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.
Secondary Outcomes
- Duration of Response (DOR)(up to 55.3 months)
- Disease Control Rate (DCR)(up to 57.1 months)
- Progression-free Survival (PFS)(up to 57.1 months)
- Overall Survival(up to 60.4 months)
- Number of Participants With Any Treatment-emergent Adverse Event (TEAE)(up to 846 days (up to approximately 2.3 years))
- First-dose Cmax of Retifanlimab(preinfusion, 10 minutes postinfusion (± 10 minutes), and 4 hours postinfusion (± 10 minutes) on Day 1 of Cycle 1)
- First-dose Cmin of Retifanlimab(preinfusion, 10 minutes postinfusion (± 10 minutes), and 4 hours postinfusion (± 10 minutes) on Day 1 of Cycle 1)
- First-dose AUC0-t of Retifanlimab(preinfusion, 10 minutes postinfusion (± 10 minutes), and 4 hours postinfusion (± 10 minutes) on Day 1 of Cycle 1)
Investigators
Study Sites (65)
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