Trial · NCT05005442
A Study of Pembrolizumab/Vibostolimab (MK-7684A) in Relapsed/Refractory Hematological Malignancies (MK-7684A-004, KEYVIBE-004)
NCT05005442, Phase 2, Completed, Merck Sharp & Dohme LLC; results first posted 2025-12-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Pembrolizumab/Vibostolimab (MK-7684A) in Relapsed/Refractory Hematological Malignancies (MK-7684A-004, KEYVIBE-004). Trials, record NCT05005442. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05005442
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Pembrolizumab/Vibostolimab (MK-7684A) in Relapsed/Refractory Hematological Malignancies (MK-7684A-004, KEYVIBE-004)
- NCT number
- NCT05005442
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 192 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Hematological Malignancies
- Interventions
- Pembrolizumab/vibostolimab coformulation
- First posted
- 2021-08-13
- Last updated
- 2026-02-19
- Other registries' IDs
- eudract:2021-001700-15
- Results first posted
- 2025-12-17
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With a Dose-Limiting Toxicity (DLT) | Up to approximately 6 weeks | A DLT is defined as an event with toxicity including the type, severity, time of onset, time of resolution, and the probable association with study treatment that are not due to pre-existing conditions as defined by the Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE 5.0). Percentage of participants who experience a DLT per CTCAE 5.0 are reported. |
| Primary | Percentage of Participants Who Experienced an Adverse Event (AE) | Up to approximately 27 months | An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. The number of participants who experience an AE are reported. |
| Primary | Percentage of Participants Who Discontinued Study Treatment Due to an AE | Up to approximately 24 months | An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. The number of participants discontinued from the study treatment due to an AE are reported. |
| Secondary | Objective Response Rate (ORR) as Assessed by Lugano 2014 Classification (Cohorts A-D & F) | Up to approximately 37 months | ORR for Cohorts A-D and F was assessed based on the Lugano 2014 Classification. ORR is defined as the percentage of the participants who had complete response (CR) or partial response (PR) and was evaluated using computed tomography (CT) and positron emission tomography (PET)-CT. CR is complete metabolic (no/minimal fluorodeoxyglucose \[FDG\] uptake) and radiologic response (target lesions regress to ≤5 cm in longest transverse diameter of a lesion) and no new lesions. PR is partial metabolic (moderate/high FDG uptake) and radiologic response (≥50% decrease in sum of product diameters for multiple lesions of up to 6 target measurable nodes and extranodal sites, no increase in lesions, and spleen regressed by \>50% in length beyond normal). ORR for Cohorts A-D and F is presented. Cohort E is presented separately. |
| Secondary | ORR as Assessed by the 2016 International Myeloma Working Group (IMWG) Response Criteria (Cohort E) | Up to approximately 37 months | ORR for Cohort E was measured by 2016 IMWG Response Criteria. ORR is defined as the percentage of the participants with either a stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) according to the International Myeloma Working Group (IMWG) Response Criteria. CR = negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND \<5% plasmacytomas in the bone marrow; sCR=stringent complete response, CR as above PLUS normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow; VGPR = serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component \<100 mg/24 hr; PR = ≥50% reduction of serum Mprotein and reduction in 24-hour urinary M-protein by ≥90% or to \<200 mg/24 hours. The ORR for Cohort E is presented. Cohorts A-D and F were presented in a previous outcome measure. |
| Secondary | Duration of Response (DOR) as Assessed by Lugano 2014 Classification (Cohorts A-D & F) | Up to approximately 37 months | For participants who demonstrate a confirmed complete response (CR) or partial response (PR), DOR is defined as the time from CR or PR to documented disease progression or death. Participants are assessed using computed tomography (CT) and positron emission tomography (PET)- CT and response was evaluated based on the Lugano 2014 Classification (Cheson et al, Journal of Clinical Oncology, 2014). CR is complete metabolic (no/minimal fluorodeoxyglucose \[FDG\] uptake) and radiologic response (target lesions regress to ≤5 cm in longest transverse diameter of a lesion) and no new lesions. PR is partial metabolic (moderate/high FDG uptake) and radiologic response (≥50% decrease in sum of product diameters (SPD) for multiple lesions of up to 6 target measurable nodes and extranodal sites, no increase in lesions, and spleen regressed by \>50% in length beyond normal). DOR for Cohorts A-D and F are presented. Cohort E is presented separately. |
| Secondary | DOR as Assessed by 2016 IMWG Response Criteria (Cohort E) | Up to approximately 37 months | DOR is defined as the time from CR or PR to documented disease progression or death. DOR for Cohort E was measured by the 2016 IMWG Response Criteria with response criteria defined as participants with either a stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR). CR = negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND \<5% plasmacytomas in the bone marrow; sCR=CR as above PLUS normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow; VGPR = serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component \<100 mg/24 hr; PR = ≥50% reduction of serum Mprotein and reduction in 24-hour urinary M-protein by ≥90% or to \<200 mg/24 hours. The DOR for Cohort E is presented. Cohorts A-D and F were presented in a previous outcome measure. |
| Secondary | Disease Control Rate (DCR) as Assessed by Lugano 2014 Classification (Cohorts A-D & F) | Up to approximately 37 months | DCR is % of participants who had tumor response per response criteria or have stable disease (SD) for ≥ 12 weeks before any evidence of progressive disease (PD). CR or PR were evaluated with CT and PET-CT. CR: complete metabolic (no/minimal FDG uptake) and radiologic response (target lesions regress to ≤5 cm in longest transverse diameter of a lesion) and no new lesions. PR: partial metabolic (moderate/high FDG uptake) and radiologic response (≥50% decrease in sum of product diameters for multiple lesions of up to 6 target measurable nodes and extranodal sites, no increase in lesions, and spleen regressed by \>50% in length beyond normal). SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. DCR for Cohorts A-D \& F are presented. Cohort E is presented in a separate outcome measure. |
| Secondary | DCR as Assessed by 2016 IMWG Response Criteria (Cohort E) | Up to approximately 37 months | DCR: percentage of participants who have achieved tumor response or have shown SD for at least 12 weeks before any evidence of PD per IMWG response criteria 2016. Response criteria are defined as participants with either a sCR, CR, VGPR, or PR. CR = negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND \<5% plasmacytomas in the bone marrow; sCR=CR as above PLUS normal serum FLC assay ratio and absence of clonal cells in bone marrow; VGPR = serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component \<100 mg/24 hr; PR = ≥50% reduction of serum Mprotein and reduction in 24-hour urinary M-protein by ≥90% or to \<200 mg/24 hours. SD = Not meeting criteria for CR, VGPR, PR, or PD. PD as defined by prespecified 2016 IMWG response criteria. DCR for Cohort E is presented. Cohorts A-D and F were presented in a previous outcome measure. |
| Secondary | Lowest Plasma Concentration (Ctrough) of Vibostolimab | Predose at Cycles 1, 3, 7, 11, 15, 19, 23, 27 and 31. Cycle = 3 weeks | Ctrough is the lowest concentration reached by a drug before the next dose is administered. Blood samples collected predose were used to determine Ctrough of Vibostolimab. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With a Dose-Limiting Toxicity (DLT) | Up to approximately 6 weeks | All participants who received at least one dose of study intervention and that finished the DLT evaluation period without a DLT or experienced a DLT in the DLT evaluation period. | Percentage of Participants | NUMBER |
| PRIMARY | Percentage of Participants Who Experienced an Adverse Event (AE) | Up to approximately 27 months | All allocated participants who received at least 1 dose of study intervention. | Percentage of Participants | NUMBER |
| PRIMARY | Percentage of Participants Who Discontinued Study Treatment Due to an AE | Up to approximately 24 months | All allocated participants who received at least 1 dose of study intervention. | Percentage of Participants | NUMBER |
| SECONDARY | Objective Response Rate (ORR) as Assessed by Lugano 2014 Classification (Cohorts A-D & F) | Up to approximately 37 months | All participants who have received at least one dose of study intervention and had ORR measured by Lugano 2014 Classification. | Percentage of Participants | NUMBER |
| SECONDARY | ORR as Assessed by the 2016 International Myeloma Working Group (IMWG) Response Criteria (Cohort E) | Up to approximately 37 months | All participants who have received at least one dose of study intervention and had ORR measured by the 2016 IMWG Response Criteria. | Percentage of Participants | NUMBER |
| SECONDARY | Duration of Response (DOR) as Assessed by Lugano 2014 Classification (Cohorts A-D & F) | Up to approximately 37 months | All participants who have received at least one dose of study intervention and had a response measured by measured by Lugano 2014 Classification. | Months | MEDIAN |
| SECONDARY | DOR as Assessed by 2016 IMWG Response Criteria (Cohort E) | Up to approximately 37 months | All participants who have received at least one dose of study intervention and had a response measured by measured by 2016 IMWG Response Criteria. No participants met the pre-specified analysis criteria for DOR in Cohort E (i.e., no participants with a response) and therefore DOR is unavailable for Cohort E. | ||
| SECONDARY | Disease Control Rate (DCR) as Assessed by Lugano 2014 Classification (Cohorts A-D & F) | Up to approximately 37 months | All participants who have received at least one dose of study intervention and were evaluated using Lugano 2014 Classification. | Percentage of Participants | NUMBER |
| SECONDARY | DCR as Assessed by 2016 IMWG Response Criteria (Cohort E) | Up to approximately 37 months | All participants who have received at least one dose of study intervention and were evaluated using 2016 IMWG Response Criteria. | Percentage of Participants | NUMBER |
| SECONDARY | Lowest Plasma Concentration (Ctrough) of Vibostolimab | Predose at Cycles 1, 3, 7, 11, 15, 19, 23, 27 and 31. Cycle = 3 weeks | All participants who received at least one dose of intervention and had data for the corresponding cycle. | ug/mL | GEOMETRIC_MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group82
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With a Dose-Limiting Toxicity (DLT) | Cohort A Pembrolizumab/Vibostolimab Coformulation | 4.8 | 95% Confidence Interval 0.8 to 14.2 | Percentage of Participants | |
| Percentage of Participants With a Dose-Limiting Toxicity (DLT) | Cohort B Pembrolizumab/Vibostolimab Coformulation | 2.4 | 95% Confidence Interval 0.1 to 10.8 | Percentage of Participants | |
| Percentage of Participants With a Dose-Limiting Toxicity (DLT) | Cohort C Pembrolizumab/Vibostolimab Coformulation | 0.0 | 95% Confidence Interval 0.0 to 14.6 | Percentage of Participants | |
| Percentage of Participants With a Dose-Limiting Toxicity (DLT) | Cohort D Pembrolizumab/Vibostolimab Coformulation | 5.0 | 95% Confidence Interval 0.3 to 20.8 | Percentage of Participants | |
| Percentage of Participants With a Dose-Limiting Toxicity (DLT) | Cohort E Pembrolizumab/Vibostolimab Coformulation | 0.0 | 95% Confidence Interval 0.0 to 23.8 | Percentage of Participants | |
| Percentage of Participants With a Dose-Limiting Toxicity (DLT) | Cohort F Pembrolizumab/Vibostolimab Coformulation | 8.0 | 95% Confidence Interval 1.4 to 22.8 | Percentage of Participants | |
| Percentage of Participants Who Experienced an Adverse Event (AE) | Cohort A Pembrolizumab/Vibostolimab Coformulation | 92.9 | Percentage of Participants | ||
| Percentage of Participants Who Experienced an Adverse Event (AE) | Cohort B Pembrolizumab/Vibostolimab Coformulation | 97.6 | Percentage of Participants | ||
| Percentage of Participants Who Experienced an Adverse Event (AE) | Cohort C Pembrolizumab/Vibostolimab Coformulation | 95.0 | Percentage of Participants | ||
| Percentage of Participants Who Experienced an Adverse Event (AE) | Cohort D Pembrolizumab/Vibostolimab Coformulation | 80.0 | Percentage of Participants |
1 to 10 of 82Source ClinicalTrials.gov
See all 82 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort A Pembrolizumab/Vibostolimab Coformulation | 42 | |
| Overall Study | STARTED | Cohort B Pembrolizumab/Vibostolimab Coformulation | 42 | |
| Overall Study | STARTED | Cohort C Pembrolizumab/Vibostolimab Coformulation | 20 | |
| Overall Study | STARTED | Cohort D Pembrolizumab/Vibostolimab Coformulation | 30 | |
| Overall Study | STARTED | Cohort E Pembrolizumab/Vibostolimab Coformulation | 25 | |
| Overall Study | STARTED | Cohort F Pembrolizumab/Vibostolimab Coformulation | 33 | |
| Overall Study | Treated | Cohort A Pembrolizumab/Vibostolimab Coformulation | 42 | |
| Overall Study | Treated | Cohort B Pembrolizumab/Vibostolimab Coformulation | 42 | |
| Overall Study | Treated | Cohort C Pembrolizumab/Vibostolimab Coformulation | 20 | |
| Overall Study | Treated | Cohort D Pembrolizumab/Vibostolimab Coformulation | 30 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events756
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 | COHORT A | 5 | 42 | 7 |
| other | Anaemia | Blood and lymphatic system disorders | COHORT B | 5 | 42 | 6 |
| other | Anaemia | Blood and lymphatic system disorders | COHORT C | 1 | 20 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | COHORT D | 5 | 30 | 5 |
| other | Anaemia | Blood and lymphatic system disorders | COHORT E | 7 | 25 | 8 |
| other | Anaemia | Blood and lymphatic system disorders | COHORT F | 4 | 32 | 5 |
| other | Eosinophilia | Blood and lymphatic system disorders | COHORT A | 3 | 42 | 3 |
| other | Eosinophilia | Blood and lymphatic system disorders | COHORT B | 1 | 42 | 1 |
| other | Eosinophilia | Blood and lymphatic system disorders | COHORT C | 0 | 20 | 0 |
| other | Eosinophilia | Blood and lymphatic system disorders | COHORT D | 1 | 30 | 1 |
1 to 10 of 756Source ClinicalTrials.gov
See all 756 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | COHORT A | 14 | 42 |
| Total, all-cause mortality | COHORT B | 10 | 42 |
| Total, all-cause mortality | COHORT C | 9 | 20 |
| Total, all-cause mortality | COHORT D | 24 | 30 |
| Total, all-cause mortality | COHORT E | 14 | 25 |
| Total, all-cause mortality | COHORT F | 15 | 33 |
| Total, other adverse events | COHORT A | 35 | 42 |
| Total, other adverse events | COHORT B | 39 | 42 |
| Total, other adverse events | COHORT C | 15 | 20 |
| Total, other adverse events | COHORT D | 21 | 30 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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.
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GET https://conductscience.org/api/trials/v1/NCT05005442/results?page=2