Trial · NCT02443324
A Study of Ramucirumab Plus Pembrolizumab in Participants With Gastric or GEJ Adenocarcinoma, NSCLC, Transitional Cell Carcinoma of the Urothelium, or Biliary Tract Cancer
NCT02443324, Phase 1, Completed, Eli Lilly and Company; results first posted 2024-07-31
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Ramucirumab Plus Pembrolizumab in Participants With Gastric or GEJ Adenocarcinoma, NSCLC, Transitional Cell Carcinoma of the Urothelium, or Biliary Tract Cancer. Trials, record NCT02443324. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02443324
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Ramucirumab Plus Pembrolizumab in Participants With Gastric or GEJ Adenocarcinoma, NSCLC, Transitional Cell Carcinoma of the Urothelium, or Biliary Tract Cancer
- NCT number
- NCT02443324
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 175 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Gastric Adenocarcinoma, Adenocarcinoma of the Gastroesophageal Junction, Non-small Cell Lung Cancer, Carcinoma, Transitional Cell, Biliary Tract Cancer
- Interventions
- Ramucirumab, Pembrolizumab
- First posted
- 2015-05-13
- Last updated
- 2024-07-31
- Other registries' IDs
- eudract:2015-001473-40
- Results first posted
- 2024-07-31
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase 1a: Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) | Cycle 1 (21 Days) | DLT is defined as an Adverse Event (AE) that is likely related to study medication or combination,and fulfills any one of following criteria:Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0): Grade (Gr) 3 and 4 nonlaboratory toxicity (tox),Any Gr 3 or 4 laboratory value if medical intervention is required to treat participant (pt) or abnormality persists for \>1 week;Hematologic tox:Gr 4 toxicity lasting ≥ 7 days,or Gr 3 thrombocytopenia if associated with bleeding and requires platelet transfusion,or Febrile neutropenia Gr 3 or Gr 4;GR 5 tox (death);Any toxicity that is possibly related to study treatment that requires withdrawal of pt from study during Cycle 1,A delay of \> 14 days due to persistent Grade ≥ 2 toxicities in initiating Cycle 2,with exception of Grade 2 fatigue;Any infusion or hypersensitivity reactions are NOT a DLT. A summary of other nonserious AEs and all Serious AEs,regardless of causality is located in Reported Adverse Event section. |
| Secondary | Phase 1a and 1b: Percentage of Participants Who Achieve Best Overall Response of Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)] | Baseline to Measured Progressive Disease (Up to 24 Months) | Overall response rate is the best response of complete response (CR) or partial response (PR) as classified by the independent central review according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. Overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants per cohort with at least 1 measurable lesion, multiplied by 100. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. |
| Secondary | Phase 1a and 1b: Percentage of Participants Who Exhibit Stable Disease (SD) or CR or PR [Disease Control Rate (DCR)] | Baseline to Measured Progressive Disease (Up to 24 Months) | Disease Control Rate (DCR) was the percentage of participants with a best overall response of CR, PR, or Stable Disease (SD) as per Response using RECIST v1.1 criteria. Participants who do not have any postbaseline tumor response assessments for any reason were considered. |
| Secondary | Phase 1a and 1b: Duration of Response (DoR) | Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up to 24 Months) | The duration of response is defined only for responders (patients with a confirmed CR or PR). It is measured from the date of first evidence of a confirmed CR or PR to the date of objective progression or the date of death due to any cause, whichever is earlier. If a responder is not known to have died or have objective progression as of the data inclusion cutoff date, DoR will be censored at the date of the last complete objective progression-free disease assessment (CR or PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. |
| Secondary | Phase 1a and 1b: Time to First Response (TTR) | Baseline to Date of CR or PR (Up to 24 Months) | TTR is defined as the time from the date of first study treatment until the first evidence of a confirmed CR or PR. |
| Secondary | Phase 1a and 1b: Progression Free Survival (PFS) | Baseline to PD or Death of Any Cause (Up to 24 Months) | PFS is defined as the time from the date of first study treatment until the date of the first observed radiographically documented progressive disease (PD) or death due to any cause, whichever is earlier. PD was determined using RECIST criteria. PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion. |
| Secondary | Phase 1a and 1b: Overall Survival (OS) | Baseline to Death from Any Cause (Up to 24 Months) | The OS time is defined as the time from baseline to the date of death from any cause. If a participant is not known to have died on or before the date of data cut-off, OS data will be censored on the last date (on or before the cut-off date) the participant was known to be alive. |
| Secondary | Phase 1a and 1b: Pharmacokinetics (PK): Minimum Trough Concentration (Cmin) of Ramucirumab | Phase 1a (Gastric-GEJ or BTC participants (pts)): Week (Wk) 1, 3, 6 and 9; Phase 1a (Gastric, NSCLC, or urothelial pts): Wk 3, 6, 9 and 12; Cohort A, A1, A2: Wk 1, 3, 6, 9, 12, 18, 19 and 24; Cohort B,C,D,E: Wk 3, 6, 9, 12, 18, 19 and 24 | PK: Cmin of Ramucirumab following administration every 3 weeks. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Phase 1a: Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) | Cycle 1 (21 Days) | All enrolled participants who received at least one dose of the study drug in dose escalation phase and experienced a DLT. DLT was assessed in Phase 1a of Cohorts A and C during Cycle 1. | participants | NUMBER |
| SECONDARY | Phase 1a and 1b: Percentage of Participants Who Achieve Best Overall Response of Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)] | Baseline to Measured Progressive Disease (Up to 24 Months) | All enrolled participants who received at least one dose of the study drug. Per Protocol, Cohort A and B participants \[Gastric-GEJ cancer (Second-Third L)\] were combined and outcome data was analyzed under a single arm (Cohort A and B). | percentage of participants | NUMBER |
| SECONDARY | Phase 1a and 1b: Percentage of Participants Who Exhibit Stable Disease (SD) or CR or PR [Disease Control Rate (DCR)] | Baseline to Measured Progressive Disease (Up to 24 Months) | All enrolled participants who received at least one dose of the study drug. Per Protocol, Cohort A and B participants \[Gastric-GEJ cancer (Second-Third L)\] were combined and outcome data was analyzed under a single arm (Cohort A and B). | percentage of participants | NUMBER |
| SECONDARY | Phase 1a and 1b: Duration of Response (DoR) | Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up to 24 Months) | All enrolled participants who received at least one dose of the study drug. Per Protocol, Cohort A and B participants \[Gastric-GEJ cancer (Second-Third L)\] were combined and outcome data was analyzed under a single arm (Cohort A and B). | months | MEDIAN |
| SECONDARY | Phase 1a and 1b: Time to First Response (TTR) | Baseline to Date of CR or PR (Up to 24 Months) | All enrolled participants who received at least one dose of the study drug. Per Protocol, Cohort A and B participants \[Gastric-GEJ cancer (Second-Third L)\] were combined and outcome data was analyzed under a single arm (Cohort A and B). | months | MEDIAN |
| SECONDARY | Phase 1a and 1b: Progression Free Survival (PFS) | Baseline to PD or Death of Any Cause (Up to 24 Months) | All enrolled participants who received at least one dose of the study drug. Censored participants: Cohort A and B = 3; Cohort A1 = 4; Cohort A2 = 8; Cohort C = 10; Cohort D = 3 and Cohort E = 13. Per Protocol, Cohort A and B participants \[Gastric-GEJ cancer (Second-Third L)\] were combined and outcome data was analyzed under a single arm (Cohort A and B). | months | MEDIAN |
| SECONDARY | Phase 1a and 1b: Overall Survival (OS) | Baseline to Death from Any Cause (Up to 24 Months) | All enrolled participants who received at least one dose of the study drug. Censored participants: Cohort A and B = 8; Cohort A1 = 8; Cohort A2 = 12; Cohort C = 12; Cohort D = 6 and Cohort E = 18. Per Protocol, Cohort A and B participants \[Gastric-GEJ cancer (Second-Third L)\] were combined and outcome data was analyzed under a single arm (Cohort A and B). | months | MEDIAN |
| SECONDARY | Phase 1a and 1b: Pharmacokinetics (PK): Minimum Trough Concentration (Cmin) of Ramucirumab | Phase 1a (Gastric-GEJ or BTC participants (pts)): Week (Wk) 1, 3, 6 and 9; Phase 1a (Gastric, NSCLC, or urothelial pts): Wk 3, 6, 9 and 12; Cohort A, A1, A2: Wk 1, 3, 6, 9, 12, 18, 19 and 24; Cohort B,C,D,E: Wk 3, 6, 9, 12, 18, 19 and 24 | All enrolled participants who received at least one dose of the study drug and had evaluable ramucirumab PK data. PK was assessed both in Phase 1a and 1b as per protocol analysis. | micrograms/milliliter (μg/mL) | GEOMETRIC_MEAN |
Source ClinicalTrials.gov
Results by group94
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Phase 1a: Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) | Cohort A | 1 | participants | ||
| Phase 1a: Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) | Cohort C | 0 | participants | ||
| Phase 1a and 1b: Percentage of Participants Who Achieve Best Overall Response of Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)] | Cohort A and B | 7.3 | 95% Confidence Interval 1.5 to 19.9 | percentage of participants | |
| Phase 1a and 1b: Percentage of Participants Who Achieve Best Overall Response of Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)] | Cohort A1 | 3.8 | 95% Confidence Interval 0.1 to 19.6 | percentage of participants | |
| Phase 1a and 1b: Percentage of Participants Who Achieve Best Overall Response of Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)] | Cohort A2 | 25.0 | 95% Confidence Interval 10.7 to 44.9 | percentage of participants | |
| Phase 1a and 1b: Percentage of Participants Who Achieve Best Overall Response of Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)] | Cohort C | 29.6 | 95% Confidence Interval 13.8 to 50.2 | percentage of participants | |
| Phase 1a and 1b: Percentage of Participants Who Achieve Best Overall Response of Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)] | Cohort D | 12.5 | 95% Confidence Interval 2.7 to 32.4 | percentage of participants | |
| Phase 1a and 1b: Percentage of Participants Who Achieve Best Overall Response of Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)] | Cohort E | 42.3 | 95% Confidence Interval 23.4 to 63.1 | percentage of participants | |
| Phase 1a and 1b: Percentage of Participants Who Exhibit Stable Disease (SD) or CR or PR [Disease Control Rate (DCR)] | Cohort A and B | 51.2 | 95% Confidence Interval 35.1 to 67.1 | percentage of participants | |
| Phase 1a and 1b: Percentage of Participants Who Exhibit Stable Disease (SD) or CR or PR [Disease Control Rate (DCR)] | Cohort A1 | 38.5 | 95% Confidence Interval 20.2 to 59.4 | percentage of participants |
1 to 10 of 94Source ClinicalTrials.gov
See all 94 results by groupParticipant flow42
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort A | 24 | |
| Overall Study | STARTED | Cohort A1 | 26 | |
| Overall Study | STARTED | Cohort A2 | 29 | |
| Overall Study | STARTED | Cohort B | 17 | |
| Overall Study | STARTED | Cohort C | 28 | |
| Overall Study | STARTED | Cohort D | 24 | |
| Overall Study | STARTED | Cohort E | 27 | |
| Overall Study | Received at Least One Dose of Study Drug | Cohort A | 24 | |
| Overall Study | Received at Least One Dose of Study Drug | Cohort A1 | 26 | |
| Overall Study | Received at Least One Dose of Study Drug | Cohort A2 | 28 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 participant flowAdverse events1,981
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 | Cohort A | 2 | 24 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort A1 | 2 | 26 | 4 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort A2 | 5 | 28 | 16 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort B | 3 | 17 | 15 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort C | 5 | 27 | 5 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort D | 2 | 24 | 4 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort E | 1 | 26 | 1 |
| other | Neutropenia | Blood and lymphatic system disorders | Cohort A | 0 | 24 | 0 |
| other | Neutropenia | Blood and lymphatic system disorders | Cohort A1 | 3 | 26 | 7 |
| other | Neutropenia | Blood and lymphatic system disorders | Cohort A2 | 0 | 28 | 0 |
1 to 10 of 1,981Source ClinicalTrials.gov
See all 1,981 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort A | 21 | 24 |
| Total, all-cause mortality | Cohort A1 | 19 | 26 |
| Total, all-cause mortality | Cohort A2 | 17 | 28 |
| Total, all-cause mortality | Cohort B | 13 | 17 |
| Total, all-cause mortality | Cohort C | 16 | 27 |
| Total, all-cause mortality | Cohort D | 18 | 24 |
| Total, all-cause mortality | Cohort E | 9 | 26 |
| Total, other adverse events | Cohort A | 23 | 24 |
| Total, other adverse events | Cohort A1 | 26 | 26 |
| Total, other adverse events | Cohort A2 | 28 | 28 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers3
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Cohort A vs Cohort C: Phase 1a: Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) |
Source Trial comparisons
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/NCT02443324
GET https://conductscience.org/api/trials/v1/NCT02443324/results?page=2