Trial · NCT04066491
Gemcitabine Plus Cisplatin With or Without Bintrafusp Alfa (M7824) in Participants With 1L BTC
NCT04066491, Phase 2, Phase 3, Terminated, EMD Serono Research & Development Institute, Inc.; results first posted 2022-06-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Gemcitabine Plus Cisplatin With or Without Bintrafusp Alfa (M7824) in Participants With 1L BTC. Trials, record NCT04066491. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04066491
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Gemcitabine Plus Cisplatin With or Without Bintrafusp Alfa (M7824) in Participants With 1L BTC
- NCT number
- NCT04066491
- Status
- Terminated
- Phases
- Phase 2, Phase 3
- Enrollment
- 309 participants, actual
- Lead sponsor
- EMD Serono Research & Development Institute, Inc.
- Conditions
- Biliary Tract Cancer, Cholangiocarcinoma, Gallbladder Cancer
- Interventions
- M7824, Placebo, Gemcitabine, Cisplatin
- First posted
- 2019-08-26
- Last updated
- 2023-11-14
- Other registries' IDs
- eudract:2019-001992-35
- Results first posted
- 2022-06-13
- Limitations and caveats
- Data collection and analysis of Pharmacokinetics and Immunogenicity were omitted and not conducted due to business reason.
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety Run-in Part: Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) | Day 1 up to Day 21 of Cycle 1 (each Cycle is of 21 days) | A DLT is a toxicity related to the study intervention that meets the following criteria as evaluated in the open-label, safety run-in: Grade 3 or 4 Immune-related adverse event (irAE) that needs permanent discontinuation of M7824 treatment; a malignant skin lesion induced by M7824 that is local and can be resected with a negative resection margin is not a DLT; Grade 3 or 4 nonhematologic toxicity other than irAE, A life threatening hematological toxicity (unless clearly attributable to chemotherapy alone), which is hardly medically manageable, including a bleeding event resulting in urgent intervention and admission to an intensive care unit and Grade 5 toxicity. |
| Primary | Double-blind Part: Overall Survival | Time from study day 1 up to data cutoff (assessed up to 609 days) | Overall Survival was defined as the time from study day 1 to the date of death due to any cause. The overall survival was analyzed by using the Kaplan-Meier method. |
| Secondary | Safety Run-in Part: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs (SAEs) and Treatment Related TEAEs According to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0 | Time from first treatment up to data cutoff (assessed up to 609 days) | Adverse Event (AE) was defined any untoward medical occurrence in a participant administered with a study drug, which does not necessarily had a causal relationship with this treatment. Serious AE was defined AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAE was defined as events with onset date or worsening during the on treatment period. TEAEs included serious TEAEs and non-serious TEAEs. |
| Secondary | Safety Run-in Part: Number of Participants With Grade Greater Than or Equal (>=) 3 Laboratory Abnormalities | Time from first treatment up to data cutoff (assessed up to 609 days) | Laboratory investigation included hematology and biochemistry. The number of participants with Grade \>=3 laboratory abnormalities were reported. Severity of grade 3 or higher TEAEs were graded using NCI-CTCAE v5.0 toxicity grades, as follows: Grade 3 = Severe; Grade 4 = Life-threatening and Grade 5 = Death. |
| Secondary | Double-blind Part: Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Independent Review Committee (IRC) | Time from randomization of study drug until the first documentation of PD or death, assessed up to 609 days | Progression free survival was defined as the time from randomization of study intervention until the first documentation of disease progression (PD) or death due to any cause in the absence of documented PD, whichever occurred first. PD: At least a 20 percent (%) increase in the sum of the longest diameter (SLD) taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. |
| Secondary | Double-blind Part: Percentage of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) | Time from randomization of study drug up to data cut off (assessed up to 609 days) | Percentage of participants with confirmed objective response that is at least one overall assessment of complete response (CR) or partial response (PR) reported here. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. Confirmed CR = at least 2 determinations of CR at least 4 weeks apart and before progression. Confirmed PR = at least 2 determinations of PR at least 4 weeks apart and before progression (and not qualifying for a CR). Confirmed objective response was determined according to RECIST v1.1 and as adjudicated by IRC. |
| Secondary | Double-blind Part: Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) | From first documented objective response to PD or death due to any cause, assessed up to 609 days | DOR was defined for participants with objective response, as the time from first documentation of objective response (confirmed Complete Response \[CR\] or Partial Response \[PR\]) to the date of first documentation of progression disease (PD) or death due to any cause, whichever occurred first. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the SLD of all lesions. PD: At least a 20 percent (%) increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. DOR was determined according to RECIST v1.1 and assessed by IRC. Results were calculated based on Kaplan-Meier estimates. |
| Secondary | Double-blind Part: Durable Response of at Least 6 Months According to Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 as Assessed by Investigator | Time from first treatment assessed up to 1148 days | Durable Response was defined as the number of participants with confirmed objective response (CR or PR) according to RECIST 1.1, determined by Investigator with duration of at least 6 months. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the SLD of all lesions. |
| Secondary | Double-blind Part: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs (SAEs), Treatment Related TEAEs and Adverse Events of Special Interest (AESIs) According to NCI-CTCAE Version 5.0 | Time from first treatment up to data cutoff (assessed up to 609 days) | AE was defined any untoward medical occurrence in a participant administered with a study drug, which does not necessarily had a causal relationship with this treatment. Serious AE was defined AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAE was defined as events with onset date or worsening during the on treatment period. TEAEs included serious TEAEs and non-serious TEAEs. Adverse events of special interest (AESI) are serious or non-serious AEs that are of clinical interest and should be closely followed. For this study, AESIs include the following: Infusion-related reactions including immediate hypersensitivity; Immune-related AEs; Transforming growth factor beta (TGFβ) inhibition mediated skin reactions; Anemia; Bleeding AEs. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Safety Run-in Part: Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) | Day 1 up to Day 21 of Cycle 1 (each Cycle is of 21 days) | The DLT analysis set included all participants who experienced at least one DLT (either by Investigator or by Safety Monitoring Committee (SMC) or who completed the safety run-in, that is the 21-day DLT evaluation period, receiving at least one infusion of M7824 and of both gemcitabine and cisplatin and not being withdrawn during the DLT evaluation period for reasons other than toxicity. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Double-blind Part: Overall Survival | Time from study day 1 up to data cutoff (assessed up to 609 days) | Intent-to-Treat analysis set included all randomized participants. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure. | Months | MEDIAN |
| SECONDARY | Safety Run-in Part: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs (SAEs) and Treatment Related TEAEs According to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0 | Time from first treatment up to data cutoff (assessed up to 609 days) | The safety run-in (SRI) analysis set includes all participants from the safety run-in part who were administered any dose of any study intervention. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Safety Run-in Part: Number of Participants With Grade Greater Than or Equal (>=) 3 Laboratory Abnormalities | Time from first treatment up to data cutoff (assessed up to 609 days) | The safety run-in (SRI) analysis set includes all participants from the safety run-in part who were administered any dose of any study intervention. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Double-blind Part: Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Independent Review Committee (IRC) | Time from randomization of study drug until the first documentation of PD or death, assessed up to 609 days | The intent-to-treat (ITT) analysis set includes all randomized participants. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure. | Months | MEDIAN |
| SECONDARY | Double-blind Part: Percentage of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) | Time from randomization of study drug up to data cut off (assessed up to 609 days) | The intent-to-treat (ITT) analysis set includes all randomized participants. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure. | Percentage of participants | NUMBER |
| SECONDARY | Double-blind Part: Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) | From first documented objective response to PD or death due to any cause, assessed up to 609 days | The intent-to-treat (ITT) analysis set includes all randomized participants. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure. | Months | MEDIAN |
| SECONDARY | Double-blind Part: Durable Response of at Least 6 Months According to Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 as Assessed by Investigator | Time from first treatment assessed up to 1148 days | Based on a review of data conducted by the Independent Data Monitoring Committee (IDMC), Sponsor decided to discontinue this study as the study was unlikely to achieve the primary objective of overall survival. Subsequently, the data for this outcome measure was not collected and analyzed. | ||
| SECONDARY | Double-blind Part: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs (SAEs), Treatment Related TEAEs and Adverse Events of Special Interest (AESIs) According to NCI-CTCAE Version 5.0 | Time from first treatment up to data cutoff (assessed up to 609 days) | Safety analysis set included all participants who were administered at least one dose of any study treatment (M7824, placebo, gemcitabine or cisplatin). | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group31
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Safety Run-in Part: Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) | Safety Run-In Part: M7824 + Gemcitabine + Cisplatin | 0 | Participants | ||
| Double-blind Part: Overall Survival | Double-blinded Part: Placebo + Gemcitabine + Cisplatin | 11.5 | Full Range 0.9 to 15.2 | Months | |
| Double-blind Part: Overall Survival | Double-blinded Part: M7824 + Gemcitabine + Cisplatin | 11.5 | Full Range 0.2 to 13.9 | Months | |
Safety Run-in Part: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs (SAEs) and Treatment Related TEAEs According to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0 | Safety Run-In Part: M7824 + Gemcitabine + Cisplatin | Participants with TEAEs | 12 | Participants | |
Safety Run-in Part: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs (SAEs) and Treatment Related TEAEs According to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0 | Safety Run-In Part: M7824 + Gemcitabine + Cisplatin | Participants with Serious TEAEs | 5 | Participants | |
Safety Run-in Part: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs (SAEs) and Treatment Related TEAEs According to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0 | Safety Run-In Part: M7824 + Gemcitabine + Cisplatin | Participants with Treatment-related TEAEs | 11 | Participants | |
| Safety Run-in Part: Number of Participants With Grade Greater Than or Equal (>=) 3 Laboratory Abnormalities | Safety Run-In Part: M7824 + Gemcitabine + Cisplatin | Hemoglobin low | 6 | Participants | |
| Safety Run-in Part: Number of Participants With Grade Greater Than or Equal (>=) 3 Laboratory Abnormalities | Safety Run-In Part: M7824 + Gemcitabine + Cisplatin | Leukocytes low | 4 | Participants | |
| Safety Run-in Part: Number of Participants With Grade Greater Than or Equal (>=) 3 Laboratory Abnormalities | Safety Run-In Part: M7824 + Gemcitabine + Cisplatin | Neutrophils low | 6 | Participants | |
| Safety Run-in Part: Number of Participants With Grade Greater Than or Equal (>=) 3 Laboratory Abnormalities | Safety Run-In Part: M7824 + Gemcitabine + Cisplatin | Platelets low | 3 | Participants |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Safety Run-In Part: M7824 + Gemcitabine + Cisplatin | 12 | |
| Overall Study | STARTED | Double-blinded Part: Placebo + Gemcitabine + Cisplatin | 149 | |
| Overall Study | STARTED | Double-blinded Part: M7824 + Gemcitabine + Cisplatin | 148 | |
| Overall Study | Treated | Safety Run-In Part: M7824 + Gemcitabine + Cisplatin | 12 | |
| Overall Study | Treated | Double-blinded Part: Placebo + Gemcitabine + Cisplatin | 149 | |
| Overall Study | Treated | Double-blinded Part: M7824 + Gemcitabine + Cisplatin | 146 | |
| Overall Study | COMPLETED | Safety Run-In Part: M7824 + Gemcitabine + Cisplatin | 12 | |
| Overall Study | COMPLETED | Double-blinded Part: Placebo + Gemcitabine + Cisplatin | 149 | |
| Overall Study | COMPLETED | Double-blinded Part: M7824 + Gemcitabine + Cisplatin | 146 | |
| Overall Study | NOT COMPLETED | Safety Run-In Part: M7824 + Gemcitabine + Cisplatin | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events615
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 | Safety Run-In Part: M7824 + Gemcitabine + Cisplatin | 6 | 12 | |
| other | Anaemia | Blood and lymphatic system disorders | Double-blinded Part: Placebo + Gemcitabine + Cisplatin | 79 | 149 | |
| other | Anaemia | Blood and lymphatic system disorders | Double-blinded Part: M7824 + Gemcitabine + Cisplatin | 78 | 146 | |
| other | Leukopenia | Blood and lymphatic system disorders | Safety Run-In Part: M7824 + Gemcitabine + Cisplatin | 1 | 12 | |
| other | Leukopenia | Blood and lymphatic system disorders | Double-blinded Part: Placebo + Gemcitabine + Cisplatin | 7 | 149 | |
| other | Leukopenia | Blood and lymphatic system disorders | Double-blinded Part: M7824 + Gemcitabine + Cisplatin | 4 | 146 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Safety Run-In Part: M7824 + Gemcitabine + Cisplatin | 1 | 12 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Double-blinded Part: Placebo + Gemcitabine + Cisplatin | 1 | 149 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Double-blinded Part: M7824 + Gemcitabine + Cisplatin | 1 | 146 | |
| other | Neutropenia | Blood and lymphatic system disorders | Safety Run-In Part: M7824 + Gemcitabine + Cisplatin | 1 | 12 |
1 to 10 of 615Source ClinicalTrials.gov
See all 615 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Safety Run-In Part: M7824 + Gemcitabine + Cisplatin | 7 | 12 |
| Total, all-cause mortality | Double-blinded Part: Placebo + Gemcitabine + Cisplatin | 26 | 149 |
| Total, all-cause mortality | Double-blinded Part: M7824 + Gemcitabine + Cisplatin | 31 | 146 |
| Total, other adverse events | Safety Run-In Part: M7824 + Gemcitabine + Cisplatin | 12 | 12 |
| Total, other adverse events | Double-blinded Part: Placebo + Gemcitabine + Cisplatin | 142 | 149 |
| Total, other adverse events | Double-blinded Part: M7824 + Gemcitabine + Cisplatin | 134 | 146 |
| Total, serious adverse events | Safety Run-In Part: M7824 + Gemcitabine + Cisplatin | 5 | 12 |
| Total, serious adverse events | Double-blinded Part: Placebo + Gemcitabine + Cisplatin | 36 | 149 |
| Total, serious adverse events | Double-blinded Part: M7824 + Gemcitabine + Cisplatin | 58 | 146 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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.
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