Trial · NCT02517398
MSB0011359C (M7824) in Metastatic or Locally Advanced Solid Tumors
NCT02517398, Phase 1, Completed, EMD Serono Research & Development Institute, Inc.; results first posted 2024-05-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. MSB0011359C (M7824) in Metastatic or Locally Advanced Solid Tumors. Trials, record NCT02517398. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02517398
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- MSB0011359C (M7824) in Metastatic or Locally Advanced Solid Tumors
- NCT number
- NCT02517398
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 600 participants, actual
- Lead sponsor
- EMD Serono Research & Development Institute, Inc.
- Conditions
- Solid Tumors
- Interventions
- MSB0011359C
- First posted
- 2015-08-07
- Last updated
- 2024-05-03
- Other registries' IDs
- eudract:2015-004366-28
- Results first posted
- 2024-05-03
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Dose-escalation: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs | From start of study drug administration up to 139 weeks | Adverse event (AE): any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. 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 | Dose-escalation: Number of Participants With Treatment-Related TEAEs, Treatment-Related Serious TEAEs and Treatment-related TEAEs Leading to Death | From start of study drug administration up to 139 weeks | Treatment-related TEAEs are any untoward medical occurrence in a participant who received study drug with causal relationship with the investigational product as assessed by the investigator. Related TEAEs were events with relationship missing, unknown or yes. Number of participants With treatment-related TEAEs, treatment-related serious TEAEs and treatment-related TEAE leading to death were reported. |
| Primary | Number of Participants With TEAEs and Related TEAEs Based on Severity According to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE) Version 4.03 | From start of study drug administration up to 139 weeks | AEs were graded according to severity using NCI-CTCAE Version 4.03. Severity of TEAEs were graded as Grade 1: mild (not causing any significant problem, dose adjustment not required), Grade 2: moderate (caused problem that does not interfere significantly with usual activities or the clinical status, dose adjustment needed due to adverse event), Grade 3: Severe (caused problem that interferes significantly with usual activities or the clinical status, study drug stopped due to adverse event), Grade 4: Life-threatening, Grade 5: Death. Number of Participants with TEAEs and Related TEAEs Based on Severity having Grade greater than or equal to (\>=) 3 and Grade \>=4 were reported. |
| Primary | Dose-escalation: Number of Participants With Dose-Limiting Toxicities According to the National Cancer Institute Common Terminology Criteria For Adverse Events(NCI-CTCAE), v4.03 | From start of study drug administration up to 21 days | A DLT was defined as any grade \>= 3 Adverse Event (AE) suspected to be related to 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. According to the NCI-CTCAE, v4.03, occurring in the DLT evaluation period and assessed to be related to study treatment by the Investigator and / or Sponsor confirmed by the safety monitoring committee to be relevant for the study treatment. |
| Primary | Dose-expansion: Number of Participants With Best Overall Response (BOR) as Assessed by Independent Endpoint Review Committee (IRC) | From date of randomization up to Week 66 | BOR according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 and as adjudicated by the Independent Endpoint Review Committee (IRC). BOR is 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% decrease in the sum of largest diameter (SLD) of the TLs, taking as a reference the baseline SLD. |
| Primary | Dose-expansion: Disease Control Rate According to Response Assessment in Neuro-Oncology (RANO) as Adjudicated by the IRC for Participants With Glioblastoma | From date of randomization up to Week 66 | DCR is defined as the percentage of participants with a confirmed CR+PR+SD+ Non-CR/non-PD at any time as per RANO criteria. A responder is a participant with a Complete Response (CR) or Partial Response (PR), and a non-responder is a participant with Stable Disease (SD) or Progressive Disease (PD) assessed by the RANO criteria. CR is no T1 gadolinium enhancing disease, no new lesions, or corticosteroids, and stable or decreasing T2-weighted-Fluid-Attenuated Inversion Recovery (T2/FLAIR). PR is ≥50% decrease in T1 gadolinium enhancing disease, no new lesions, stable or decreasing T2/FLAIR or corticosteroids, and stable or increasing clinical status. SD is \<50% decrease in T1 gadolinium enhancing disease but \< 25% increase, no new lesions, stable or decreasing T2/FLAIR or corticosteroids, and stable or increase in clinical status. PD is ≥25% increase in T1 gadolinium enhancing disease. |
| Secondary | Maximum Concentration (Cmax) of M7824 in Plasma | 0 hours (pre-dose), 1, 4, 10, 25, 72, 168, 240, 336 hours post-dose | Cmax was obtained directly from the concentration versus time curve. |
| Secondary | Area Under the Concentration-Time Curve From Time Zero up to Time Tau (AUCtau) of M7824 | 0 hours (pre-dose), 1, 4, 10, 25, 72, 168, 240, 336 hours post-dose post-dose | Area under the concentration-time curve from time zero up to time Tau, where Tau is the dosing interval (336 hours). |
| Secondary | Apparent Terminal Half Life (t1/2) of M7824 | Pre-dose, 0, 1, 4, 10, 25, 72, 168, 240, 336 hours post-dose | Terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life is calculated by dividing the natural logarithm to the base e (Log e) multiplied by (\*) 2/ λz, where 'λz' is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. |
| Secondary | Trough Plasma Concentration (Ctrough) of M7824 | 0 hours (Pre-dose), 1, 4, 10, 25, 72, 168, 240, 336 hours post-dose | Ctrough is the plasma concentration of a drug prior to administration. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Dose-escalation: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs | From start of study drug administration up to 139 weeks | Safety Analysis Set (SAS) included all randomized participants who received at least 1 dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Dose-escalation: Number of Participants With Treatment-Related TEAEs, Treatment-Related Serious TEAEs and Treatment-related TEAEs Leading to Death | From start of study drug administration up to 139 weeks | SAS included all randomized participants who received at least 1 dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With TEAEs and Related TEAEs Based on Severity According to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE) Version 4.03 | From start of study drug administration up to 139 weeks | SAS included all randomized participants who received at least 1 dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Dose-escalation: Number of Participants With Dose-Limiting Toxicities According to the National Cancer Institute Common Terminology Criteria For Adverse Events(NCI-CTCAE), v4.03 | From start of study drug administration up to 21 days | DLT Analysis Set included all participants who received all study treatment administrations in the DLT-evaluation period or stopped treatment because of DLTs in the DLT-evaluation period. Data was planned not to be collected and analyzed for the arms: Dose-escalation: M7824 0.3 - 10 mg/kg, Dose-escalation: M7824 1 - 1200 mg and Dose-escalation: HCC-3 mg/kg. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Dose-expansion: Number of Participants With Best Overall Response (BOR) as Assessed by Independent Endpoint Review Committee (IRC) | From date of randomization up to Week 66 | FAS included all participants who received at least 1 dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Dose-expansion: Disease Control Rate According to Response Assessment in Neuro-Oncology (RANO) as Adjudicated by the IRC for Participants With Glioblastoma | From date of randomization up to Week 66 | FAS included all participants who received at least 1 dose of study treatment. Data was planned, collected and analyzed only for participants with glioblastoma. | Percentage of participants | NUMBER |
| SECONDARY | Maximum Concentration (Cmax) of M7824 in Plasma | 0 hours (pre-dose), 1, 4, 10, 25, 72, 168, 240, 336 hours post-dose | PK Analysis Set included all who received at least 1 dose of study treatment, and who provided at least 1 post-baseline sample with a measurable concentration. Here, 'Overall number of participants analyzed' signifies participants who were evaluable for this outcome measure. As per planned analysis combined PK data was collected for the dose cohorts (\[1 mg/kg +1-1200 mg/kg and 3 mg/kg +HCC-3 mg/kg\]) in dose escalation and 1200mg of all solid tumors in dose expansion. | micrograms per milliliter (mcg/ml) | GEOMETRIC_MEAN |
| SECONDARY | Area Under the Concentration-Time Curve From Time Zero up to Time Tau (AUCtau) of M7824 | 0 hours (pre-dose), 1, 4, 10, 25, 72, 168, 240, 336 hours post-dose post-dose | Pharmacokinetic Analysis Set included all participants who received at least 1 dose of IMP, and who provided at least 1 post-baseline sample with a measurable concentration of IMP. Here, 'Overall number of participants analyzed' signifies participants who were evaluable for this outcome measure. As per planned analysis combined PK data was collected for the dose cohorts (\[1 mg/kg +1-1200 mg/kg and 3 mg/kg +HCC-3 mg/kg\]) in dose escalation and 1200mg of all solid tumors in dose expansion. | hour*microgram per milliliter (h*mcg/ml) | GEOMETRIC_MEAN |
| SECONDARY | Apparent Terminal Half Life (t1/2) of M7824 | Pre-dose, 0, 1, 4, 10, 25, 72, 168, 240, 336 hours post-dose | Pharmacokinetic Analysis Set included all participants who received at least 1 dose of IMP, and who provided at least 1 post-baseline sample with a measurable concentration of IMP. Here, 'Overall number of participants analyzed' signifies participants who were evaluable for this outcome measure. As per planned analysis combined PK data was collected for the dose cohorts (\[1 mg/kg +1-1200 mg/kg and 3 mg/kg +HCC-3 mg/kg\]) in dose escalation and 1200mg of all solid tumors in dose expansion. | Hour | GEOMETRIC_MEAN |
| SECONDARY | Trough Plasma Concentration (Ctrough) of M7824 | 0 hours (Pre-dose), 1, 4, 10, 25, 72, 168, 240, 336 hours post-dose | Pharmacokinetic Analysis Set included all participants who received at least 1 dose of IMP, and who provided at least 1 post-baseline sample with a measurable concentration of IMP. Here, 'Overall number of participants analyzed' signifies participants who were evaluable for this outcome measure. As per planned analysis combined PK data was collected for the dose cohorts (\[1 mg/kg +1-1200 mg/kg and 3 mg/kg +HCC-3 mg/kg\]) in dose escalation and 1200mg of all solid tumors in dose expansion. | mcg/mL | GEOMETRIC_MEAN |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group356
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Dose-escalation: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs | Dose-escalation: M7824 0.3 - 10 mg/kg | Participants with TEAEs | 3 | Participants | |
| Dose-escalation: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs | Dose-escalation: M7824 1 mg/kg | Participants with TEAEs | 3 | Participants | |
| Dose-escalation: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs | Dose-escalation: M7824 1 - 1200 mg | Participants with TEAEs | 4 | Participants | |
| Dose-escalation: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs | Dose-escalation: M7824 3 mg/kg | Participants with TEAEs | 3 | Participants | |
| Dose-escalation: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs | Dose-escalation: M7824 10 mg/kg | Participants with TEAEs | 6 | Participants | |
| Dose-escalation: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs | Dose-escalation: M7824 20 mg/kg | Participants with TEAEs | 10 | Participants | |
| Dose-escalation: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs | Dose-escalation: M7824 30 mg/kg | Participants with TEAEs | 7 | Participants | |
| Dose-escalation: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs | Dose-escalation: M7824 2400 mg/Infusion | Participants with TEAEs | 3 | Participants | |
| Dose-escalation: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs | Dose-escalation: HCC-3 mg/kg | Participants with TEAEs | 6 | Participants | |
| Dose-escalation: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs | Dose-escalation: M7824 0.3 - 10 mg/kg | Participants with Serious TEAEs | 2 | Participants |
1 to 10 of 356Source ClinicalTrials.gov
See all 356 results by groupParticipant flow69
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dose-escalation: M7824 0.3 - 10 mg/kg | 3 | |
| Overall Study | STARTED | Dose-escalation: M7824 1 mg/kg | 3 | |
| Overall Study | STARTED | Dose-escalation: M7824 1 - 1200 mg | 4 | |
| Overall Study | STARTED | Dose-escalation: M7824 3 mg/kg | 3 | |
| Overall Study | STARTED | Dose-escalation: M7824 10 mg/kg | 6 | |
| Overall Study | STARTED | Dose-escalation: M7824 20 mg/kg | 10 | |
| Overall Study | STARTED | Dose-escalation: M7824 30 mg/kg | 7 | |
| Overall Study | STARTED | Dose-escalation: M7824 2400 mg/Infusion | 3 | |
| Overall Study | STARTED | Dose-escalation: HCC-3 mg/kg | 6 | |
| Overall Study | STARTED | Dose-expansion: HCC Ascending Dose 1200mg | 38 |
1 to 10 of 69Source ClinicalTrials.gov
See all 69 participant flowAdverse events12,581
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 | Dose-escalation: M7824 0.3 - 10 mg/kg | 1 | 3 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | Dose-escalation: M7824 1 mg/kg | 0 | 3 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Dose-escalation: M7824 1 - 1200 mg | 1 | 4 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Dose-escalation: M7824 10 mg/kg | 2 | 6 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | Dose-escalation: M7824 20 mg/kg | 5 | 10 | 13 |
| other | Anaemia | Blood and lymphatic system disorders | Dose-escalation: M7824 2400 mg/Infusion | 2 | 3 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | Dose-escalation: M7824 3 mg/kg | 1 | 3 | 5 |
| other | Anaemia | Blood and lymphatic system disorders | Dose-escalation: M7824 30 mg/kg | 4 | 7 | 12 |
| other | Anaemia | Blood and lymphatic system disorders | Dose-expansion: Cervical Cancer | 7 | 15 | 18 |
| other | Anaemia | Blood and lymphatic system disorders | Dose-expansion: Colorectal Carcinoma | 10 | 32 | 32 |
1 to 10 of 12,581Source ClinicalTrials.gov
See all 12,581 adverse eventsAdverse event totals69
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dose-escalation: M7824 0.3 - 10 mg/kg | 2 | 3 |
| Total, all-cause mortality | Dose-escalation: M7824 1 mg/kg | 3 | 3 |
| Total, all-cause mortality | Dose-escalation: M7824 1 - 1200 mg | 4 | 4 |
| Total, all-cause mortality | Dose-escalation: M7824 10 mg/kg | 3 | 6 |
| Total, all-cause mortality | Dose-escalation: M7824 20 mg/kg | 8 | 10 |
| Total, all-cause mortality | Dose-escalation: M7824 2400 mg/Infusion | 2 | 3 |
| Total, all-cause mortality | Dose-escalation: M7824 3 mg/kg | 3 | 3 |
| Total, all-cause mortality | Dose-escalation: M7824 30 mg/kg | 3 | 7 |
| Total, all-cause mortality | Dose-expansion: Cervical Cancer | 8 | 15 |
| Total, all-cause mortality | Dose-expansion: Colorectal Carcinoma | 23 | 32 |
1 to 10 of 69Source ClinicalTrials.gov
See all 69 adverse event totalsPapers9
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.
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