Trial · NCT04761198
A Study of Etigilimab and Nivolumab in Participants With Locally Advanced or Metastatic Tumors
NCT04761198, Phase 1, Phase 2, Completed, Mereo BioPharma; results first posted 2025-03-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Etigilimab and Nivolumab in Participants With Locally Advanced or Metastatic Tumors. Trials, record NCT04761198. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04761198
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Etigilimab and Nivolumab in Participants With Locally Advanced or Metastatic Tumors
- NCT number
- NCT04761198
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 76 participants, actual
- Lead sponsor
- Mereo BioPharma
- Conditions
- Solid Tumor, Adult, Advanced Solid Tumor, Metastatic Solid Tumor
- Interventions
- Etigilimab, Nivolumab
- First posted
- 2021-02-18
- Last updated
- 2025-03-17
- Other registries' IDs
- eudract:2020-004222-37
- Results first posted
- 2025-03-17
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) as Assessed Based on Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1) | From first dose of study drug until the date of first objective response (CR or PR) (maximum exposure: 638 days) | The ORR was defined as the percentage of participants who achieved a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) per RECIST v1.1. CR: Disappearance of all target or non-target lesions and normalization of tumor marker level. Any pathological lymph node (whether target or non-target) must have reduction in short axis to \<10 millimeters (mm). PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. |
| Secondary | Number of Participants WithTreatment-emergent Adverse Events (TEAEs), Any Adverse Events of Special Interests (AESIs), AESI Immune Related AEs, and AESI Infusion Reactions | From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) | TEAEs were defined as adverse events (AEs) with an onset date on or after the date of first administration of study drug up to 100 days after the last dose of study drug and before starting any subsequent cancer treatment. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AESIs were defined as events (serious or non-serious) which were of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor might be appropriate. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'. |
| Secondary | Disease Control Rate (DCR) as Assessed Based on RECIST v1.1 | From first dose of study drug until the date of first BOR (CR, PR, or SD) (maximum exposure: 638 days) | The DCR was defined as the percentage of participants who achieved CR, PR, and stable disease (SD). CR: Disappearance of all target or non-target lesions and normalization of tumor marker level. Any pathological lymph node (whether target or non-target) must have reduction in short axis to \<10 mm. PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. SD: Persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits; and no new lesions. |
| Secondary | Duration of Response (DoR) as Assessed Based on RECIST v1.1 | From first dose of study drug until the date of first overall response of PD or date of death due to underlying cancer (maximum exposure: 638 days) | The DoR was defined as the time, in days, from the first of the 2 assessments required for confirmed PR or CR to the time of the progressive disease (PD) or death due to underlying cancer. CR: Disappearance of all target or non-target lesions and normalization of tumor marker level. Any pathological lymph node (whether target or non-target) must have reduction in short axis to \<10 mm. PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. PD: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of the existing non-target lesions. The appearance of one or more new lesions was also considered progression. |
| Secondary | Duration of Stable Disease (DoSD) as Assessed Based on RECIST v1.1 | From first dose of study drug until the date of first overall response of PD or date of death due to underlying cancer (up to a maximum of 680 days) | The DoSD was defined as the time, in days, from the first date of treatment until the first date at which PD was experienced or the participant died due to underlying cancer. PD: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of the existing non-target lesions. The appearance of one or more new lesions was also considered progression. |
| Secondary | Serum Concentrations of Etigilimab | Pre-infusion and 15 minutes post-infusion on Cycle 1 Day 1 and Cycle 4 Day 43 | |
| Secondary | Number of Participants With Anti-drug Antibodies (ADA) to Etigilimab | From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate (ORR) as Assessed Based on Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1) | From first dose of study drug until the date of first objective response (CR or PR) (maximum exposure: 638 days) | RE Analysis Set included all participants with measurable disease at baseline who received study drug and had at least 1 post-baseline response assessment or discontinued treatment due to disease progression (including death due to disease progression) within 16 weeks (+ a 2-week window) of the first dose of study drug. Per planned analysis, the efficacy data for Cohort F were collected and analyzed separately per tumor type. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants WithTreatment-emergent Adverse Events (TEAEs), Any Adverse Events of Special Interests (AESIs), AESI Immune Related AEs, and AESI Infusion Reactions | From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) | Safety Analysis Set included all participants who received any amount of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Disease Control Rate (DCR) as Assessed Based on RECIST v1.1 | From first dose of study drug until the date of first BOR (CR, PR, or SD) (maximum exposure: 638 days) | RE Analysis Set included all participants with measurable disease at baseline who received study drug and had at least 1 post-baseline response assessment or discontinued treatment due to disease progression (including death due to disease progression) within 16 weeks (+ a 2-week window) of the first dose of study drug. Per planned analysis, the efficacy data for Cohort F were collected and analyzed separately per tumor type. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DoR) as Assessed Based on RECIST v1.1 | From first dose of study drug until the date of first overall response of PD or date of death due to underlying cancer (maximum exposure: 638 days) | RE Analysis Set: all participants with measurable disease at baseline who received study drug and had at least 1 post-baseline response assessment or discontinued treatment due to disease progression (including death due to disease progression) within 16 weeks of first dose of study drug. Per planned analysis, the efficacy data for Cohort F were collected and analyzed separately per tumor type. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. | days | MEDIAN |
| SECONDARY | Duration of Stable Disease (DoSD) as Assessed Based on RECIST v1.1 | From first dose of study drug until the date of first overall response of PD or date of death due to underlying cancer (up to a maximum of 680 days) | RE Analysis Set included all participants with measurable disease at baseline who received study drug and had at least 1 post-baseline response assessment or discontinued treatment due to disease progression (including death due to disease progression) within 16 weeks (+ a 2-week window) of the first dose of study drug. Per planned analysis, the efficacy data for Cohort F were collected and analyzed separately per tumor type. | days | MEDIAN |
| SECONDARY | Serum Concentrations of Etigilimab | Pre-infusion and 15 minutes post-infusion on Cycle 1 Day 1 and Cycle 4 Day 43 | The pharmacokinetic (PK) analysis set included all participants with sufficient plasma concentration data to allow the characterization of the PK parameters. Per planned analysis, PK data were collected and analyzed combined for all arm groups. 'Number analyzed' = participants evaluable at specified timepoint. | micrograms (μg)/milliliter (mL) | GEOMETRIC_MEAN |
| SECONDARY | Number of Participants With Anti-drug Antibodies (ADA) to Etigilimab | From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) | The immunogenicity analysis set included all participants with at least 1 evaluable post-treatment immunogenicity sample. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group75
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate (ORR) as Assessed Based on Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1) | Cohort A: Endometrial Cancer CPI (PD-1/PD-L1) Naive | 20.0 | 95% Confidence Interval 2.52 to 55.61 | percentage of participants | |
| Objective Response Rate (ORR) as Assessed Based on Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1) | Cohort B: Head and Neck Squamous Cell Carcinoma | 0 | 95% Confidence Interval 0.00 to 97.50 | percentage of participants | |
| Objective Response Rate (ORR) as Assessed Based on Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1) | Cohort C: Cervical Carcinoma | 37.5 | 95% Confidence Interval 8.52 to 75.51 | percentage of participants | |
| Objective Response Rate (ORR) as Assessed Based on Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1) | Cohort E: TMB-H + MSS Solid Tumors | 0 | 95% Confidence Interval 0.00 to 33.63 | percentage of participants | |
| Objective Response Rate (ORR) as Assessed Based on Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1) | Cohort F: Rare Tumors (Uveal) | 25.0 | 95% Confidence Interval 3.19 to 65.09 | percentage of participants | |
| Objective Response Rate (ORR) as Assessed Based on Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1) | Cohort F: Rare Tumors (De-diff LPS) | 10.0 | 95% Confidence Interval 0.25 to 44.50 | percentage of participants | |
| Objective Response Rate (ORR) as Assessed Based on Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1) | Cohort F: Rare Tumors (UPS) | 16.7 | 95% Confidence Interval 0.42 to 64.12 | percentage of participants | |
| Objective Response Rate (ORR) as Assessed Based on Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1) | Cohort F: Rare Tumors (Other Sarcoma) | 0 | 95% Confidence Interval 0.00 to 70.76 | percentage of participants | |
| Objective Response Rate (ORR) as Assessed Based on Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1) | Cohort F: Rare Tumors (GCT) | 0 | 95% Confidence Interval 0.00 to 60.24 | percentage of participants | |
| Objective Response Rate (ORR) as Assessed Based on Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1) | Cohort G: Endometrial Cancer Post- CPI (PD-1/PD-L1 Treated) | 0 | 95% Confidence Interval 0.00 to 70.76 | percentage of participants |
1 to 10 of 75Source ClinicalTrials.gov
See all 75 results by groupParticipant flow35
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort A: Endometrial Cancer CPI (PD-1/PD-L1) Naive | 11 | |
| Overall Study | STARTED | Cohort B: Head and Neck Squamous Cell Carcinoma | 1 | |
| Overall Study | STARTED | Cohort C: Cervical Carcinoma | 8 | |
| Overall Study | STARTED | Cohort E: TMB-H + MSS Solid Tumors | 9 | |
| Overall Study | STARTED | Cohort F: Rare Tumors (Sarcoma, Uveal Melanoma, Germ Cell) | 33 | |
| Overall Study | STARTED | Cohort G: Endometrial Cancer Post- CPI (PD-1/PD-L1 Treated) | 4 | |
| Overall Study | STARTED | Cohort H: Ovarian Cancer | 10 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Cohort A: Endometrial Cancer CPI (PD-1/PD-L1) Naive | 11 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Cohort B: Head and Neck Squamous Cell Carcinoma | 1 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Cohort C: Cervical Carcinoma | 8 |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 participant flowAdverse events490
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 | Nausea | Gastrointestinal disorders | Cohort A: Endometrial Cancer CPI (PD-1/PD-L1) Naive | 4 | 11 | |
| other | Nausea | Gastrointestinal disorders | Cohort B: Head and Neck Squamous Cell Carcinoma | 0 | 1 | |
| other | Nausea | Gastrointestinal disorders | Cohort C: Cervical Carcinoma | 3 | 8 | |
| other | Nausea | Gastrointestinal disorders | Cohort E: TMB-H + MSS Solid Tumors | 3 | 9 | |
| other | Nausea | Gastrointestinal disorders | Cohort F: Rare Tumors (Sarcoma, Uveal Melanoma, Germ Cell) | 6 | 33 | |
| other | Nausea | Gastrointestinal disorders | Cohort G: Endometrial Cancer Post- CPI (PD-1/PD-L1 Treated) | 0 | 4 | |
| other | Nausea | Gastrointestinal disorders | Cohort H: Ovarian Cancer | 5 | 10 | |
| other | Diarrhoea | Gastrointestinal disorders | Cohort A: Endometrial Cancer CPI (PD-1/PD-L1) Naive | 4 | 11 | |
| other | Diarrhoea | Gastrointestinal disorders | Cohort B: Head and Neck Squamous Cell Carcinoma | 0 | 1 | |
| other | Diarrhoea | Gastrointestinal disorders | Cohort C: Cervical Carcinoma | 4 | 8 |
1 to 10 of 490Source ClinicalTrials.gov
See all 490 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort A: Endometrial Cancer CPI (PD-1/PD-L1) Naive | 2 | 11 |
| Total, all-cause mortality | Cohort B: Head and Neck Squamous Cell Carcinoma | 1 | 1 |
| Total, all-cause mortality | Cohort C: Cervical Carcinoma | 2 | 8 |
| Total, all-cause mortality | Cohort E: TMB-H + MSS Solid Tumors | 5 | 9 |
| Total, all-cause mortality | Cohort F: Rare Tumors (Sarcoma, Uveal Melanoma, Germ Cell) | 14 | 33 |
| Total, all-cause mortality | Cohort G: Endometrial Cancer Post- CPI (PD-1/PD-L1 Treated) | 2 | 4 |
| Total, all-cause mortality | Cohort H: Ovarian Cancer | 5 | 10 |
| Total, other adverse events | Cohort A: Endometrial Cancer CPI (PD-1/PD-L1) Naive | 11 | 11 |
| Total, other adverse events | Cohort B: Head and Neck Squamous Cell Carcinoma | 1 | 1 |
| Total, other adverse events | Cohort C: Cervical Carcinoma | 8 | 8 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 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.
GET https://conductscience.org/api/trials/v1/NCT04761198
GET https://conductscience.org/api/trials/v1/NCT04761198/results?page=2