Phase 2
Completed N=107
A Study of INCMGA00012 in Metastatic Merkel Cell Carcinoma (POD1UM-201)
Metastatic Merkel Cell Carcinoma
Source: ClinicalTrials.gov NCT03599713 ↗
Enrolled (actual)
107
Serious AEs
26.2%
Results posted
May 2023
Primary outcomePrimary: Objective Response Rate (ORR) — 52.3 percentage of participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate (ORR) |
52.3 | — |
| SECONDARY Duration of Response (DOR) |
NA | — |
| SECONDARY Disease Control Rate (DCR) |
60.4 | — |
| SECONDARY Progression-free Survival (PFS) |
16.03 | — |
| SECONDARY Overall Survival |
NA | — |
| SECONDARY Number of Participants With Any Treatment-emergent Adverse Event (TEAE) |
92; 5 | — |
| SECONDARY First-dose Cmax of Retifanlimab |
144 | — |
| SECONDARY First-dose Cmin of Retifanlimab |
20.5 | — |
| SECONDARY First-dose AUC0-t of Retifanlimab |
1770 | — |
Eligibility Criteria
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 1.
- Measurable disease according to RECIST v1.1.
- 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.
Data sourced from ClinicalTrials.gov (NCT03599713). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.