Phase 1
Completed N=175
A Study of Ramucirumab Plus Pembrolizumab in Participants With Gastric or GEJ Adenocarcinoma, NSCLC, Transitional Cell Carcinoma of the Urothelium, or Biliary Tract Cancer
gastric adenocarcinoma · adenocarcinoma of the gastroesophageal junction · Non-Small Cell Lung Cancer · Carcinoma, Transitional Cell
Source: ClinicalTrials.gov NCT02443324 ↗
Enrolled (actual)
175
Serious AEs
55.8%
Results posted
Jul 2024
Primary outcomePrimary: Phase 1a: Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) — 1; 0 participants
Summary
The main purpose of this study is to evaluate the safety and preliminary efficacy of the combination of the study drug known as ramucirumab plus pembrolizumab in participants with locally advanced and unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma, non-small cell lung cancer (NSCLC), transitional cell carcinoma of the urothelium, or biliary tract cancer (BTC).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Phase 1a: Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) |
1; 0 | — |
| 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)] |
7.3; 3.8; 25.0; 29.6; 12.5; 42.3 | — |
| SECONDARY Phase 1a and 1b: Percentage of Participants Who Exhibit Stable Disease (SD) or CR or PR [Disease Control Rate (DCR)] |
51.2; 38.5; 67.9; 85.2; 50.0; 84.6 | — |
| SECONDARY Phase 1a and 1b: Duration of Response (DoR) |
6.7; 6.0; NA; NA; 8.3; NA | — |
| SECONDARY Phase 1a and 1b: Time to First Response (TTR) |
1.4; 2.7; 2.7; 2.1; 2.8; 1.4 | — |
| SECONDARY Phase 1a and 1b: Progression Free Survival (PFS) |
2.5; 1.6; 5.6; 9.7; 1.9; 9.3 | — |
| SECONDARY Phase 1a and 1b: Overall Survival (OS) |
5.9; 6.4; 14.6; 26.2; 6.4; NA | — |
| SECONDARY Phase 1a and 1b: Pharmacokinetics (PK): Minimum Trough Concentration (Cmin) of Ramucirumab |
50.9; 44.2; 45.2; 45.9; 52; 20.9 | — |
Eligibility Criteria
Inclusion Criteria
- Metastatic disease or locally advanced, unresectable disease.
- Has histopathologically confirmed gastric or GEJ adenocarcinoma with documented disease progression after 0-2 prior lines of systemic therapy
- Has histopathologically confirmed nonsquamous or squamous NSCLC with documented disease progression after 0-3 prior lines of systemic therapy
- Has histopathologically confirmed transitional cell carcinoma of the urothelium (bladder, urethra, or renal pelvis) with documented disease progression after 1-3 prior lines of systemic therapy
- Has histologically confirmed biliary tract adenocarcinoma with documented progression after 1-2 prior lines of systemic therapy
- Availability of tumor tissue for biomarker analysis from a newly obtained core or excisional biopsy or willing to undergo a tumor biopsy. For first line NSCLC participants only, PD-L1 expression should be 1% or higher.
- Have an Eastern Cooperative Oncology Group Performance Status of 0 or 1.
- Has adequate organ function.
- Have an anticipated life expectancy of ≥3 months.
Exclusion Criteria
- Have known brain metastases.
- Has received ≥3 lines of prior systemic therapy for gastric or GEJ adenocarcinoma and BTC or ≥4 lines for NSCLC or urothelial cancer.
- Has active autoimmune disease.
- Known human immunodeficiency virus (HIV) infection.
- Known active hepatitis B or hepatitis C infection.
- Has received any previous systemic therapy targeting vascular endothelial growth factor (VEGF) or VEGF receptor, or programmed death (PD) 1 or PD-ligand 1/2 signaling pathways.
- Have received a live vaccine within 30 days prior to enrollment. Seasonal flu vaccines that do not contain live virus are permitted.
- Have had a serious or non-healing wound, ulcer, or bone fracture within 28 days prior to enrollment.
- Have an elective or a planned major surgery during the course of the trial or has undergone major surgery within 28 days prior to enrollment.
Data sourced from ClinicalTrials.gov (NCT02443324). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.