Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02720068 | Study of Favezelimab (MK-4280) as Monotherapy and in Combination With Pembrolizumab (MK-3475) With or Without Chemotherapy or Lenvatinib (MK-7902) AND Favezelimab/Pembrolizumab (MK-4280A) as Monotherapy in Adults With Advanced Solid Tumors (MK-4280-001) | PHASE1 | COMPLETED | 481 | — | — | May 2, 2016 | Mar 15, 2024 | May 30, 2025 | - | — |
DLTs were assessed during the first cycle (21 days) \& were defined as: Grade (Gr) 4 nonhematologic toxicity; Gr 4 hematologic toxicity lasting ≥7 days, except Gr 4 thrombocytopenia of any duration or Gr 3 thrombocytopenia associated with bleeding; Gr 3 nonhematologic toxicity lasting ≥3 days despite optimal supportive care (with exceptions); Gr 3 or 4 nonhematologic lab abnormality (if medical intervention was required, lead to hospitalization, or persisted for \>1 week); Gr 3 or 4 febrile neutropenia; any drug-related AE that caused the participant to discontinue treatment during Cycle 1; Grade 5 toxicity; Any treatment-related toxicity that causes ≥2-week delay in initiation of Cycle 2.
An AE was defined as any untoward medical occurrence in a participant administered study treatment and which did not necessarily have to have a causal relationship with this treatment. The number of participants who experienced an AE is presented.
An AE was defined as any untoward medical occurrence in a participant administered study treatment and which did not necessarily have to have a causal relationship with this treatment. The number of participants who discontinued study treatment due to an AE is presented.
| Arm | Type | Description |
|---|---|---|
| Part A: Favezelimab 7 mg Monotherapy | EXPERIMENTAL | Participants received favezelimab 7 mg intravenous (IV) infusion on Day 1 of each 21-day cycle. |
| Part A: Favezelimab 21 mg Monotherapy | EXPERIMENTAL | Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle. |
| Part A: Favezelimab 70 mg Monotherapy | EXPERIMENTAL | Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle. |
| Part A: Favezelimab 210 mg Monotherapy | EXPERIMENTAL | Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle. |
| Part A: Favezelimab 700 mg Monotherapy | EXPERIMENTAL | Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle. |
| Part A: Favezelimab 7 mg + Pembrolizumab 200 mg | EXPERIMENTAL | Participants received favezelimab 7 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle. |
| Part A: Favezelimab 21 mg + Pembrolizumab 200 mg | EXPERIMENTAL | Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle. |
| Part A: Favezelimab 70 mg + Pembrolizumab 200 mg | EXPERIMENTAL | Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle. |
| Part A: Favezelimab 210 mg + Pembrolizumab 200 mg | EXPERIMENTAL | Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle. |
| Part A: Favezelimab 700 mg + Pembrolizumab 200 mg | EXPERIMENTAL | Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle. |
| Part B: Favezelimab 800 mg Monotherapy (Arm 1) | EXPERIMENTAL | Participants received favezelimab 800 mg monotherapy IV infusion on Day 1 of each 21-day cycle. |
| Part B: Favezelimab 200 mg + Pembrolizumab 200 mg (Arm 2A) | EXPERIMENTAL | Participants received favezelimab 200 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle. |
| Part B: Favezelimab 700 mg + Pembrolizumab 200 mg (Arm 2B) | EXPERIMENTAL | Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle. |
| Part B: Favezelimab 800 mg + Pembrolizumab 200 mg (Arm 2C) | EXPERIMENTAL | Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle. |
| Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + mFOLFOX7 (Arm 3) | EXPERIMENTAL | Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS mFOLFOX7 (oxaliplatin 85 mg/m\^2 IV, leucovorin \[calcium folinate\] 400 mg/m\^2 IV, and fluorouracil \[5-FU\] 2400 mg/m\^2 IV over 46 to 48 hours, every 2 weeks \[Q2W\]). |
| Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + FOLFIRI (Arm 4) | EXPERIMENTAL | Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS FOLFIRI (irinotecan 180 mg/m\^2 IV, leucovorin \[calcium folinate\] 400 mg/m\^2 IV and 5-FU 2400 mg/m\^2 IV over 46 to 48 hours, Q2W). |
| Part B: MK-4280A (Arm 5) | EXPERIMENTAL | Participants received MK-4280A, a coformulation of favezelimab 800 mg + pembrolizumab 200 mg IV infusion on Day 1 of each 21-day cycle. |
| Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + Lenvatinib 20 mg (Arm 6) | EXPERIMENTAL | Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS oral lenvatinib 20 mg once daily. |
| Name | Type | Description |
|---|---|---|
| Favezelimab | BIOLOGICAL | IV infusion |
| Pembrolizumab | BIOLOGICAL | IV infusion |
| Oxaliplatin | DRUG | IV infusion |
| Irinotecan | DRUG | IV infusion |
| Leucovorin (Calcium Folinate) | DRUG | IV infusion |
| Fluorouracil [5-FU] | DRUG | IV infusion |
| Favezelimab/Pembrolizumab | BIOLOGICAL | IV infusion |
| Lenvatinib | DRUG | Oral |
Inclusion Criteria: * Part A and Part B: Has histologically or cytologically-confirmed metastatic solid tumor. * Has measurable disease by immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) 1.1 criteria. * Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Gr...