Trial · NCT02699515
MSB0011359C (M7824) in Participants With Metastatic or Locally Advanced Solid Tumors
NCT02699515, Phase 1, Completed, Merck KGaA, Darmstadt, Germany; results first posted 2024-11-18
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. MSB0011359C (M7824) in Participants With Metastatic or Locally Advanced Solid Tumors. Trials, record NCT02699515. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02699515
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- MSB0011359C (M7824) in Participants With Metastatic or Locally Advanced Solid Tumors
- NCT number
- NCT02699515
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 114 participants, actual
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Conditions
- Solid Tumors
- Interventions
- MSB0011359C
- First posted
- 2016-03-04
- Last updated
- 2024-11-18
- Results first posted
- 2024-11-18
- Limitations and caveats
- Data collection and analysis of Pharmacokinetics of Cmin was omitted and not conducted due to business reason.
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Dose Limiting Toxicity (DLT) | Baseline up to Week 3 | A DLT was defined as any grade greater than or equal to (\>=) 3 adverse event suspected to be related to investigational medicinal product (IMP) by the Investigator and / or Sponsor occurring in the DLT evaluation period confirmed by the Safety Monitoring Committee (SMC) to be relevant for the IMP treatment. |
| Primary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) According to National Cancer Institute-Common Terminology Criteria for Adverse Event (NCI-CTCAE) Version 4.03 | First study drug administration up to 30 days after the last drug administration assessed up to approximately 5 years | An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. Serious AE: an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAE: AE with onset after start of treatment or with onset date before the treatment start date but worsening after the treatment start date. TEAEs included both serious and non-serious TEAEs. |
| Primary | Number of Participants With Treatment-Related Adverse Events (TRAEs) According to NCI-CTCAE Version 4.03 | First study drug administration up to 30 days after the last drug administration assessed up to approximately 5 years | An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. Serious AE: an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAE: AE with onset after start of treatment or with onset date before the treatment start date but worsening after the treatment start date. TEAEs included both serious and non-serious TEAEs. Treatment-related TEAEs: reasonably related to the study intervention. Number of participants with TEAEs and treatment related TEAEs were reported. |
| Secondary | Dose-Escalation Phase: Maximum Serum Concentration (Cmax) of M7824 | Pre-dose, 0, 4 hour post dose on Day 1, 2,8,15,29,43 | Cmax is the maximum observed serum concentration obtained directly from the concentration versus time curve. |
| Secondary | Dose-Escalation Phase: Terminal Half Life (t1/2) of M7824 | Pre-dose, 0, 4 hour post dose on Day 1, 2,8,15,29,43 | t1/2 was the time measured for the concentration to decrease by one half, determined as 0.693/Lambda z, here Lambda z was the terminal elimination rate constant determined by log-linear regression analysis of the measured serum concentrations of the terminal log-linear phase. |
| Secondary | Dose-Escalation Phase: Area Under the Serum Concentration Time Curve From Zero to Last Sampling Time (AUC0-t) of M7824 | Pre-dose, 0, 4 hour post dose on Day 1, 2, 8, 15, 29, 43 | Area under the serum concentration versus time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLOQ). AUC0-t was calculated by linear trapezoidal summation. |
| Secondary | Dose-Escalation Phase: Area Under The Concentration Time Curve From Time Zero to Infinity (AUC0-inf) of M7824 | Pre-dose, 0, 4 hour post dose on Day 1, 2, 8, 15, 29, 43 | The AUC(0-inf) was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity. |
| Secondary | Dose-Escalation Phase: Number of Participants With Positive Serum Titers of Anti-Drug Antibodies of M7824 | Predose, Day 15, 43, 85 and every 6-weekly until progression or end of the treatment whichever occur first, assessed up to 3 years | The detection of antibodies to M7824 was performed using a validated electrochemiluminescence (ECL) immunoassay with tiered testing of screening, confirmatory and titration. Number of participants with positive anti-drug antibody (ADA) of M7824 were reported. |
| Secondary | Dose-Escalation Part: Number of Participants With Best Overall Response (BOR) As Assessed By Investigator | Date of randomization up to 2 years | BOR was assessed by investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. BOR was defined as sum of complete response and partial response (CR+PR). For target lesions (TLs), CR was defined as the disappearance of all TLs; PR was defined as at least a 30 percent (%) decrease in the sum of largest diameter (SLD) of the TLs, taking as a reference the baseline SLD. |
| Secondary | Expansion Part: Best Overall Response (BOR) As Assessed By Investigator | Date of randomization up to 2 years | BOR was assessed by investigator according to RECIST Version 1.1. BOR was defined as sum of CR and PR. For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30 percent (%) decrease in the SLD of the TLs, taking as a reference the baseline SLD. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Dose Limiting Toxicity (DLT) | Baseline up to Week 3 | DLT analysis set included all participants with data used for implementing the dose-escalation schedule. These participants received all study treatment administrations in the DLT evaluation period or stopped treatment because of DLTs in the DLT evaluation period. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) According to National Cancer Institute-Common Terminology Criteria for Adverse Event (NCI-CTCAE) Version 4.03 | First study drug administration up to 30 days after the last drug administration assessed up to approximately 5 years | Safety Analysis Set (SAF) included all participants who received at least 1 dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Treatment-Related Adverse Events (TRAEs) According to NCI-CTCAE Version 4.03 | First study drug administration up to 30 days after the last drug administration assessed up to approximately 5 years | Safety analysis set included all participants who received at least 1 dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Dose-Escalation Phase: Maximum Serum Concentration (Cmax) of M7824 | Pre-dose, 0, 4 hour post dose on Day 1, 2,8,15,29,43 | Pharmacokinetic analysis set included all participants who completed at least 1 infusion of M7824, and who provided at least 1 post dose sample with a measurable concentration of M7824. Here, Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Micrograms per milliliter (mcg/mL) | GEOMETRIC_MEAN |
| SECONDARY | Dose-Escalation Phase: Terminal Half Life (t1/2) of M7824 | Pre-dose, 0, 4 hour post dose on Day 1, 2,8,15,29,43 | Pharmacokinetic analysis set included all participants who completed at least 1 infusion of M7824, and who provided at least 1 post dose sample with a measurable concentration of M7824. Here, Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | hours | GEOMETRIC_MEAN |
| SECONDARY | Dose-Escalation Phase: Area Under the Serum Concentration Time Curve From Zero to Last Sampling Time (AUC0-t) of M7824 | Pre-dose, 0, 4 hour post dose on Day 1, 2, 8, 15, 29, 43 | Pharmacokinetic analysis set included all participants who completed at least 1 infusion of M7824, and who provided at least 1 post dose sample with a measurable concentration of M7824. Here, Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | hour*microgram per milliliter(hr*mcg/mL) | GEOMETRIC_MEAN |
| SECONDARY | Dose-Escalation Phase: Area Under The Concentration Time Curve From Time Zero to Infinity (AUC0-inf) of M7824 | Pre-dose, 0, 4 hour post dose on Day 1, 2, 8, 15, 29, 43 | Pharmacokinetic analysis set included all participants who completed at least 1 infusion of M7824, and who provided at least 1 post dose sample with a measurable concentration of M7824. Here, Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | hr*mcg/mL | GEOMETRIC_MEAN |
| SECONDARY | Dose-Escalation Phase: Number of Participants With Positive Serum Titers of Anti-Drug Antibodies of M7824 | Predose, Day 15, 43, 85 and every 6-weekly until progression or end of the treatment whichever occur first, assessed up to 3 years | Immunogenicity Analysis Set included participants who received at least 1 dose of study drug and who had at least 1 valid result of ADA at any time point. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Dose-Escalation Part: Number of Participants With Best Overall Response (BOR) As Assessed By Investigator | Date of randomization up to 2 years | Full analysis set included all participants who received at least 1 dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Expansion Part: Best Overall Response (BOR) As Assessed By Investigator | Date of randomization up to 2 years | Full analysis set included all participants who received at least 1 dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group112
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Dose Limiting Toxicity (DLT) | Dose Escalation Cohort: M7824 (3 mg/kg) | 0 | Participants | ||
| Number of Participants With Dose Limiting Toxicity (DLT) | Dose Escalation Cohort: M7824 (10 mg/kg) | 0 | Participants | ||
| Number of Participants With Dose Limiting Toxicity (DLT) | Dose Escalation Cohort: M7824 (20 mg/kg) | 1 | Participants | ||
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) According to National Cancer Institute-Common Terminology Criteria for Adverse Event (NCI-CTCAE) Version 4.03 | Dose Escalation Cohort: M7824 (3 mg/kg) | 4 | Participants | ||
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) According to National Cancer Institute-Common Terminology Criteria for Adverse Event (NCI-CTCAE) Version 4.03 | Dose Escalation Cohort: M7824 (10 mg/kg) | 3 | Participants | ||
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) According to National Cancer Institute-Common Terminology Criteria for Adverse Event (NCI-CTCAE) Version 4.03 | Dose Escalation Cohort: M7824 (20 mg/kg) | 6 | Participants | ||
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) According to National Cancer Institute-Common Terminology Criteria for Adverse Event (NCI-CTCAE) Version 4.03 | Expansion Cohort: Biliary Tract Cancer | 28 | Participants | ||
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) According to National Cancer Institute-Common Terminology Criteria for Adverse Event (NCI-CTCAE) Version 4.03 | Expansion Cohort: Gastric Cancer (GC) | 30 | Participants | ||
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) According to National Cancer Institute-Common Terminology Criteria for Adverse Event (NCI-CTCAE) Version 4.03 | Expansion Cohort: Esophageal Squamous Cell Cancer | 30 | Participants | ||
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) According to National Cancer Institute-Common Terminology Criteria for Adverse Event (NCI-CTCAE) Version 4.03 | Expansion Cohort: Hepatocellular Carcinoma (3 mg/kg) | 2 | Participants |
1 to 10 of 112Source ClinicalTrials.gov
See all 112 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dose Escalation Cohort: M7824 (3 mg/kg) | 4 | |
| Overall Study | STARTED | Dose Escalation Cohort: M7824 (10 mg/kg) | 3 | |
| Overall Study | STARTED | Dose Escalation Cohort: M7824 (20 mg/kg) | 7 | |
| Overall Study | STARTED | Expansion Cohort: Biliary Tract Cancer | 30 | |
| Overall Study | STARTED | Expansion Cohort: Gastric Cancer (GC) | 31 | |
| Overall Study | STARTED | Expansion Cohort: Esophageal Squamous Cell Cancer | 30 | |
| Overall Study | STARTED | Expansion Cohort: Hepatocellular Carcinoma (3 mg/kg) | 3 | |
| Overall Study | STARTED | Expansion Cohort: Hepatocellular Carcinoma (10 mg/kg) | 6 | |
| Overall Study | COMPLETED | Dose Escalation Cohort: M7824 (3 mg/kg) | 0 | |
| Overall Study | COMPLETED | Dose Escalation Cohort: M7824 (10 mg/kg) | 0 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events2,744
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 | Expansion Cohort: Biliary Tract Cancer | 10 | 30 | 15 |
| other | Anaemia | Blood and lymphatic system disorders | Expansion Cohort: Gastric Cancer (GC) | 11 | 31 | 16 |
| other | Anaemia | Blood and lymphatic system disorders | Expansion Cohort: Esophageal Squamous Cell Cancer | 7 | 30 | 11 |
| other | Anaemia | Blood and lymphatic system disorders | Dose Escalation Cohort: M7824 (3 mg/kg) | 3 | 4 | 3 |
| other | Anaemia | Blood and lymphatic system disorders | Dose Escalation Cohort: M7824 (10 mg/kg) | 0 | 3 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Dose Escalation Cohort: M7824 (20 mg/kg) | 2 | 7 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | Expansion Cohort: Hepatocellular Carcinoma (3 mg/kg) | 0 | 3 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Expansion Cohort: Hepatocellular Carcinoma (10 mg/kg) | 1 | 6 | 1 |
| other | Disseminated intravascular coagulation | Blood and lymphatic system disorders | Expansion Cohort: Biliary Tract Cancer | 0 | 30 | 0 |
| other | Disseminated intravascular coagulation | Blood and lymphatic system disorders | Expansion Cohort: Gastric Cancer (GC) | 1 | 31 | 1 |
1 to 10 of 2,744Source ClinicalTrials.gov
See all 2,744 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Expansion Cohort: Biliary Tract Cancer | 23 | 30 |
| Total, all-cause mortality | Expansion Cohort: Gastric Cancer (GC) | 22 | 31 |
| Total, all-cause mortality | Expansion Cohort: Esophageal Squamous Cell Cancer | 24 | 30 |
| Total, all-cause mortality | Dose Escalation Cohort: M7824 (3 mg/kg) | 3 | 4 |
| Total, all-cause mortality | Dose Escalation Cohort: M7824 (10 mg/kg) | 3 | 3 |
| Total, all-cause mortality | Dose Escalation Cohort: M7824 (20 mg/kg) | 3 | 7 |
| Total, all-cause mortality | Expansion Cohort: Hepatocellular Carcinoma (3 mg/kg) | 3 | 3 |
| Total, all-cause mortality | Expansion Cohort: Hepatocellular Carcinoma (10 mg/kg) | 5 | 6 |
| Total, other adverse events | Expansion Cohort: Biliary Tract Cancer | 28 | 30 |
| Total, other adverse events | Expansion Cohort: Gastric Cancer (GC) | 30 | 31 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers4
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.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02699515
GET https://conductscience.org/api/trials/v1/NCT02699515/results?page=2