Trial · NCT03427411
Results by group21
Each measurement the trial posted, group by group, in the words and numbers it posted.
1 to 20 of 21
Download this page as JSON| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants That Achieved an Objective Confirmed Complete or Partial Overall Tumor Response | Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | 31 | 95% Confidence Interval 15.3 to 50.8 | percentage of participants | |
| Percentage of Participants That Achieved an Objective Confirmed Complete or Partial Overall Tumor Response | Participants Refractory to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | 7.7 | 95% Confidence Interval 0.9 to 25.1 | percentage of participants | |
| Progression-free Survival Time (PFS) | Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | 3.5 | 95% Confidence Interval 1.5 to 7.4 | Months | |
| Progression-free Survival Time (PFS) | Participants Refractory to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | 1.4 | 95% Confidence Interval 0.0 to 9.2 | Months | |
Percentage of Participants With Disease Control Who Achieved a Complete Response, Partial Response and Stable Disease Defined by the Response Evaluation Criteria in Solid Tumors (RECIST)Version 1.1 Lasting at Least 6 Months | Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | 62.1 | 95% Confidence Interval 42.3 to 79.3 | percentage of participants | |
Percentage of Participants With Disease Control Who Achieved a Complete Response, Partial Response and Stable Disease Defined by the Response Evaluation Criteria in Solid Tumors (RECIST)Version 1.1 Lasting at Least 6 Months | Participants Refractory to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | 19.2 | 95% Confidence Interval 6.6 to 39.4 | percentage of participants | |
| Overall Survival (OS) | Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | 19.2 | 95% Confidence Interval 9.7 to NA | Months | |
| Overall Survival (OS) | Participants Refractory to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | 4.4 | 95% Confidence Interval 2.7 to 13.2 | Months | |
| Number of Participants With Serious Grade ≥3 Adverse Events Considered Related to Study Treatment of M7824 | Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | 6 | Participants | ||
| Number of Participants With Serious Grade ≥3 Adverse Events Considered Related to Study Treatment of M7824 | Participants Refractory to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | 4 | Participants | ||
| Number of Checkpoint Inhibitor Naive Participants With Response Based on Adequate Similarity (Defined as P-value > 0.2 With Fisher's Exact Test) of Results in Cohorts 1 and 2 | Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | Complete Response | 2 | Participants | |
| Number of Checkpoint Inhibitor Naive Participants With Response Based on Adequate Similarity (Defined as P-value > 0.2 With Fisher's Exact Test) of Results in Cohorts 1 and 2 | Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | Partial Response | 7 | Participants | |
| Number of Checkpoint Inhibitor Naive Participants With Response Based on Adequate Similarity (Defined as P-value > 0.2 With Fisher's Exact Test) of Results in Cohorts 1 and 2 | Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | Progressive Disease | 10 | Participants | |
| Number of Checkpoint Inhibitor Naive Participants With Response Based on Adequate Similarity (Defined as P-value > 0.2 With Fisher's Exact Test) of Results in Cohorts 1 and 2 | Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | Stable Disease | 9 | Participants | |
| Number of Checkpoint Inhibitor Naive Participants With Response Based on Adequate Similarity (Defined as P-value > 0.2 With Fisher's Exact Test) of Results in Cohorts 1 and 2 | Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | Not Evaluable | 1 | Participants | |
| Percentage of Participants That Were Hospitalized Because of Adverse Events Attributed to Disease Progression | Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | 37.9 | percentage of participants | ||
| Percentage of Participants That Were Hospitalized Because of Adverse Events Attributed to Disease Progression | Participants Refractory to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | 69.2 | percentage of participants | ||
| Duration of Response (Complete Response or Partial Response) | Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | NA | 95% Confidence Interval 8.3 to NA | Months | |
| Duration of Response (Complete Response or Partial Response) | Participants Refractory to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | 4.0 | 95% Confidence Interval 2.8 to NA | Months | |
| Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) | Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | 30 | Participants |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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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