Trial · 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)
NCT02720068, Phase 1, Completed, Merck Sharp & Dohme LLC; results first posted 2025-05-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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). Trials, record NCT02720068. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02720068
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
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)
- NCT number
- NCT02720068
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 481 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Neoplasms
- Interventions
- Favezelimab, Pembrolizumab, Oxaliplatin, Irinotecan, Leucovorin (Calcium Folinate), Fluorouracil [5-FU], Favezelimab/Pembrolizumab, Lenvatinib
- First posted
- 2016-03-25
- Last updated
- 2025-05-30
- Other registries' IDs
- eudract:2017-001464-38
- Results first posted
- 2025-05-30
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Who Experienced a Dose-Limiting Toxicity (DLT) | Up to 21 days (Cycle 1) | 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. |
| Primary | Number of Participants Who Experienced an Adverse Event (AE) | Up to approximately 31.3 months | 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. |
| Primary | Number of Participants Who Discontinued Study Treatment Due to an AE | Up to approximately 28.3 months | 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. |
| Secondary | Objective Response Rate (ORR) for Part B Participants | Up to approximately 92 months | ORR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experienced a CR or PR is presented. |
| Secondary | Area Under the Curve From Time 0 to Infinity (AUC0-inf) of Favezelimab | Predose, 2 hours post start of infusion, and post infusion on Day 1 of cycles 1-4 and 8; Day 2 postdose in cycle 1; Days 8 and 15 in cycles 2, 4, and 8; and at the discontinuation and safety follow-up visit if performed prior to the end of Cycle 8 | Blood for serum samples was collected at pre-specified time points to determine the AUC0-inf of favezelimab. In addition to time points listed in Time Frame, participants enrolled in mainland China also had samples drawn predose on Day 1 of Cycle 5 and postdose on Day 2 of Cycles 4 and 8. Per protocol, different arms had different sampling schedules and therefore were not analyzed for all cycles. |
| Secondary | Area Under the Curve From Time 0 to 21 Days (AUC0-21 Days) of Favezelimab | Predose, 2 hours post start of infusion, and post infusion on Day 1 of cycles 1-4 and 8; Day 2 postdose in cycle 1; Days 8 and 15 in cycles 2, 4, and 8; and at the discontinuation and safety follow-up visit if performed prior to the end of Cycle 8 | Blood for serum samples was collected at pre-specified time points to determine the AUC0-21 Days of favezelimab. In addition to time points listed in Time Frame, participants enrolled in mainland China also had samples drawn predose on Day 1 of Cycle 5 and postdose on Day 2 of Cycles 4 and 8. Per protocol, different arms had different sampling schedules and therefore were not analyzed for all cycles. |
| Secondary | Maximum Serum Concentration (Cmax) of Favezelimab | Predose, 2 hours post start of infusion, and post infusion on Day 1 of cycles 1-4 and 8; Day 2 postdose in cycle 1; Days 8 and 15 in cycles 2, 4, and 8; and at the discontinuation and safety follow-up visit if performed prior to the end of Cycle 8 | Blood for serum samples was collected at pre-specified time points to determine the Cmax of favezelimab. In addition to time points listed in Time Frame, participants enrolled in mainland China also had samples drawn predose on Day 1 of Cycle 5 and postdose on Day 2 of Cycles 4 and 8. Per protocol, different arms had different sampling schedules and therefore were not analyzed for all cycles. |
| Secondary | AUC0-inf of Pembrolizumab | Predose, 2 hours post start of infusion, and post infusion on Day 1 of cycles 1-4 and 8; Day 2 postdose in cycle 1; Days 8 and 15 in cycles 2, 4, and 8; and at the discontinuation and safety follow-up visit if performed prior to the end of Cycle 8 | Blood for serum samples was collected at pre-specified time points to determine the AUC0-inf of pembrolizumab. In addition to time points listed in Time Frame, participants enrolled in mainland China also had samples drawn predose on Day 1 of Cycle 5 and postdose on Day 2 of Cycles 4 and 8. Per protocol, different arms had different sampling schedules and therefore were not analyzed for all cycles. |
| Secondary | AUC0-21 Days of Pembrolizumab | Predose, 2 hours post start of infusion, and post infusion on Day 1 of cycles 1-4 and 8; Day 2 postdose in cycle 1; Days 8 and 15 in cycles 2, 4, and 8; and at the discontinuation and safety follow-up visit if performed prior to the end of Cycle 8 | Blood for serum samples was collected at pre-specified time points to determine the AUC0-21 Days of pembrolizumab. In addition to time points listed in Time Frame, participants enrolled in mainland China also had samples drawn predose on Day 1 of Cycle 5 and postdose on Day 2 of Cycles 4 and 8. Per protocol, different arms had different sampling schedules and therefore were not analyzed for all cycles. |
| Secondary | Cmax of Pembrolizumab | Predose, 2 hours post start of infusion, and post infusion on Day 1 of cycles 1-4 and 8; Day 2 postdose in cycle 1; Days 8 and 15 in cycles 2, 4, and 8; and at the discontinuation and safety follow-up visit if performed prior to the end of Cycle 8 | Blood for serum samples was collected at pre-specified time points to determine the Cmax of pembrolizumab. In addition to time points listed in Time Frame, participants enrolled in mainland China also had samples drawn predose on Day 1 of Cycle 5 and postdose on Day 2 of Cycles 4 and 8. Per protocol, different arms had different sampling schedules and therefore were not analyzed for all cycles. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Who Experienced a Dose-Limiting Toxicity (DLT) | Up to 21 days (Cycle 1) | All participants who received ≥1 dose of study treatment prior to determination of maximum tolerated dose, and were observed for safety for 21 days after their first dose of assigned treatment or experienced a DLT prior to 21 days after their first dose of assigned treatment. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Who Experienced an Adverse Event (AE) | Up to approximately 31.3 months | All participants who received ≥1 dose of study treatment | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Who Discontinued Study Treatment Due to an AE | Up to approximately 28.3 months | All participants who received ≥1 dose of study treatment | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Objective Response Rate (ORR) for Part B Participants | Up to approximately 92 months | All participants enrolled in Part B with a baseline scan with measurable disease by investigator assessment, who received ≥1 dose of study treatment | Percentage of Participants | NUMBER |
| SECONDARY | Area Under the Curve From Time 0 to Infinity (AUC0-inf) of Favezelimab | Predose, 2 hours post start of infusion, and post infusion on Day 1 of cycles 1-4 and 8; Day 2 postdose in cycle 1; Days 8 and 15 in cycles 2, 4, and 8; and at the discontinuation and safety follow-up visit if performed prior to the end of Cycle 8 | All participants who complied with the protocol sufficiently to ensure that generated data likely exhibiting the effects of treatment, according to the underlying scientific model | Day*μg/mL | GEOMETRIC_MEAN |
| SECONDARY | Area Under the Curve From Time 0 to 21 Days (AUC0-21 Days) of Favezelimab | Predose, 2 hours post start of infusion, and post infusion on Day 1 of cycles 1-4 and 8; Day 2 postdose in cycle 1; Days 8 and 15 in cycles 2, 4, and 8; and at the discontinuation and safety follow-up visit if performed prior to the end of Cycle 8 | All participants who complied with the protocol sufficiently to ensure that generated data likely exhibiting the effects of treatment, according to the underlying scientific model | Day*μg/mL | GEOMETRIC_MEAN |
| SECONDARY | Maximum Serum Concentration (Cmax) of Favezelimab | Predose, 2 hours post start of infusion, and post infusion on Day 1 of cycles 1-4 and 8; Day 2 postdose in cycle 1; Days 8 and 15 in cycles 2, 4, and 8; and at the discontinuation and safety follow-up visit if performed prior to the end of Cycle 8 | All participants who complied with the protocol sufficiently to ensure that generated data likely exhibiting the effects of treatment, according to the underlying scientific model | μg/mL | GEOMETRIC_MEAN |
| SECONDARY | AUC0-inf of Pembrolizumab | Predose, 2 hours post start of infusion, and post infusion on Day 1 of cycles 1-4 and 8; Day 2 postdose in cycle 1; Days 8 and 15 in cycles 2, 4, and 8; and at the discontinuation and safety follow-up visit if performed prior to the end of Cycle 8 | All participants who complied with the protocol sufficiently to ensure that generated data likely exhibiting the effects of treatment, according to the underlying scientific model | Day*μg/mL | GEOMETRIC_MEAN |
| SECONDARY | AUC0-21 Days of Pembrolizumab | Predose, 2 hours post start of infusion, and post infusion on Day 1 of cycles 1-4 and 8; Day 2 postdose in cycle 1; Days 8 and 15 in cycles 2, 4, and 8; and at the discontinuation and safety follow-up visit if performed prior to the end of Cycle 8 | All participants who complied with the protocol sufficiently to ensure that generated data likely exhibiting the effects of treatment, according to the underlying scientific model | Day*μg/mL | GEOMETRIC_MEAN |
| SECONDARY | Cmax of Pembrolizumab | Predose, 2 hours post start of infusion, and post infusion on Day 1 of cycles 1-4 and 8; Day 2 postdose in cycle 1; Days 8 and 15 in cycles 2, 4, and 8; and at the discontinuation and safety follow-up visit if performed prior to the end of Cycle 8 | All participants who complied with the protocol sufficiently to ensure that generated data likely exhibiting the effects of treatment, according to the underlying scientific model | μg/mL | GEOMETRIC_MEAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group526
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Who Experienced a Dose-Limiting Toxicity (DLT) | Part A: Favezelimab 7 mg Monotherapy | 0 | Participants | ||
| Number of Participants Who Experienced a Dose-Limiting Toxicity (DLT) | Part A: Favezelimab 21 mg Monotherapy | 0 | Participants | ||
| Number of Participants Who Experienced a Dose-Limiting Toxicity (DLT) | Part A: Favezelimab 70 mg Monotherapy | 0 | Participants | ||
| Number of Participants Who Experienced a Dose-Limiting Toxicity (DLT) | Part A: Favezelimab 210 mg Monotherapy | 0 | Participants | ||
| Number of Participants Who Experienced a Dose-Limiting Toxicity (DLT) | Part A: Favezelimab 700 mg Monotherapy | 0 | Participants | ||
| Number of Participants Who Experienced a Dose-Limiting Toxicity (DLT) | Part A: Favezelimab 7 mg + Pembrolizumab 200 mg | 0 | Participants | ||
| Number of Participants Who Experienced a Dose-Limiting Toxicity (DLT) | Part A: Favezelimab 21 mg + Pembrolizumab 200 mg | 0 | Participants | ||
| Number of Participants Who Experienced a Dose-Limiting Toxicity (DLT) | Part A: Favezelimab 70 mg + Pembrolizumab 200 mg | 0 | Participants | ||
| Number of Participants Who Experienced a Dose-Limiting Toxicity (DLT) | Part A: Favezelimab 210 mg + Pembrolizumab 200 mg | 0 | Participants | ||
| Number of Participants Who Experienced a Dose-Limiting Toxicity (DLT) | Part A: Favezelimab 700 mg + Pembrolizumab 200 mg | 0 | Participants |
1 to 10 of 526Source ClinicalTrials.gov
See all 526 results by groupParticipant flow108
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Part A: Favezelimab 7 mg Monotherapy | 3 | |
| Overall Study | STARTED | Part A: Favezelimab 21 mg Monotherapy | 6 | |
| Overall Study | STARTED | Part A: Favezelimab 70 mg Monotherapy | 3 | |
| Overall Study | STARTED | Part A: Favezelimab 210 mg Monotherapy | 3 | |
| Overall Study | STARTED | Part A: Favezelimab 700 mg Monotherapy | 3 | |
| Overall Study | STARTED | Part A: Favezelimab 7 mg + Pembrolizumab 200 mg | 3 | |
| Overall Study | STARTED | Part A: Favezelimab 21 mg + Pembrolizumab 200 mg | 3 | |
| Overall Study | STARTED | Part A: Favezelimab 70 mg + Pembrolizumab 200 mg | 3 | |
| Overall Study | STARTED | Part A: Favezelimab 210 mg + Pembrolizumab 200 mg | 3 | |
| Overall Study | STARTED | Part A: Favezelimab 700 mg + Pembrolizumab 200 mg | 3 |
1 to 10 of 108Source ClinicalTrials.gov
See all 108 participant flowAdverse events6,260
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Part A: Favezelimab 7 mg Monotherapy | 0 | 3 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Part A: Favezelimab 21 mg Monotherapy | 0 | 6 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Part A: Favezelimab 70 mg Monotherapy | 1 | 3 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Part A: Favezelimab 210 mg Monotherapy | 1 | 3 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Part A: Favezelimab 700 mg Monotherapy | 1 | 3 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Part A: Favezelimab 7 mg + Pembrolizumab 200 mg | 0 | 3 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Part A: Favezelimab 21 mg + Pembrolizumab 200 mg | 0 | 3 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Part A: Favezelimab 70 mg + Pembrolizumab 200 mg | 0 | 3 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Part A: Favezelimab 210 mg + Pembrolizumab 200 mg | 0 | 3 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Part A: Favezelimab 700 mg + Pembrolizumab 200 mg | 1 | 3 | 1 |
1 to 10 of 6,260Source ClinicalTrials.gov
See all 6,260 adverse eventsAdverse event totals60
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part A: Favezelimab 7 mg Monotherapy | 3 | 3 |
| Total, all-cause mortality | Part A: Favezelimab 21 mg Monotherapy | 4 | 6 |
| Total, all-cause mortality | Part A: Favezelimab 70 mg Monotherapy | 3 | 3 |
| Total, all-cause mortality | Part A: Favezelimab 210 mg Monotherapy | 1 | 3 |
| Total, all-cause mortality | Part A: Favezelimab 700 mg Monotherapy | 2 | 3 |
| Total, all-cause mortality | Part A: Favezelimab 7 mg + Pembrolizumab 200 mg | 1 | 3 |
| Total, all-cause mortality | Part A: Favezelimab 21 mg + Pembrolizumab 200 mg | 2 | 3 |
| Total, all-cause mortality | Part A: Favezelimab 70 mg + Pembrolizumab 200 mg | 2 | 3 |
| Total, all-cause mortality | Part A: Favezelimab 210 mg + Pembrolizumab 200 mg | 3 | 3 |
| Total, all-cause mortality | Part A: Favezelimab 700 mg + Pembrolizumab 200 mg | 2 | 3 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36493599 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02720068
GET https://conductscience.org/api/trials/v1/NCT02720068/results?page=2