Status:
COMPLETED
A Study of Multiple Immunotherapy-Based Treatment Combinations in Patients With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Cancer (G/GEJ) or Esophageal Cancer (Morpheus-Gastric and Esophageal Cancer)
Lead Sponsor:
Hoffmann-La Roche
Collaborating Sponsors:
Halozyme Therapeutics
BioLineRx, Ltd.
Conditions:
Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma or Esophageal Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
A Phase Ib/II, open label, multi-center, randomized study designed to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of immunotherapy-based treatment combination...
Eligibility Criteria
Inclusion
- Gastric Cancer Cohorts
- Age \>/= 18 years;
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
- Life expectancy \>/= 3 months, as determined by the investigator;
- Histologically or cytologically confirmed locally advanced unresectable or metastatic adenocarcinoma of gastric or gastroesophageal junction; (for the 1L Gastric Cancer Cohort: no prior systemic therapy for the locally advanced or metastatic disease; for the 2L Gastric Cancer Cohort: disease progression during or following a first-line platinum-containing or fluoropyrimidine-containing chemotherapy regimen);
- Availability of a representative tumor specimen that is suitable for determination of PD-L1 and TIGIT levels by IHC and/or additional biomarker status by means of retrospective central testing;
- Only for the 1L Gastric Cancer Cohort: human epidermal growth factor receptor 2 (HER2)-negative tumors;
- Measurable disease (at least one target lesion) according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1);
- Adequate hematologic and end organ function based on laboratory results obtained within 14 days prior to initiation of study treatment;
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures as outlined for each specific treatment arm;
- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as outlined for each specific treatment arm.
- Esophageal Cancer Cohort
- Histologically or cytologically confirmed diagnosis of squamous cell carcinoma or adenocarcinoma of the esophagus in locally advanced or metastatic disease;
- No prior systemic treatment for esophageal cancer, with the following exception:
- For patients treated with chemotherapy in the locally advanced setting: occurrence of metastasis after 6 months from the last dose of chemotherapy;
- For patients with adenocarcinoma: absence of HER2 expression;
- Life expectancy \>/=3 months as determined by the investigator;
- Measurable disease per RECIST v1.1;
- Adequate hematologic and end-organ function;
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating eggs;
- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm;
- ECOG Performance Status of 0, 1, or 2.
Exclusion
- Exclusion criteria for the 2L Gastric Cancer Cohort:
- Urinary protein is \> 1 + on dipstick and the required following 24-hour urine collection shows urinary protein \> 2000 mg;
- Serious or non-healing wound, peptic ulcer, or bone fracture within 28 days prior to initiation of study treatment;
- History of gastrointestinal perforation and/or fistulae within 6 months prior to initiation of study treatment;
- Presence of a bowel obstruction, history or presence of inflammatory enteropathy, or extensive intestinal resection, Crohn disease, ulcerative colitis, or chronic diarrhea;
- Uncontrolled arterial hypertension \>/= 150/ \>/= 90 millimeter of mercury (mmHg) despite standard medical management;
- Chronic therapy with non-steroidal anti-inflammatory agents or other anti-platelet agents.
- Gastric Cancer
Key Trial Info
Start Date :
October 13 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 9 2025
Estimated Enrollment :
214 Patients enrolled
Trial Details
Trial ID
NCT03281369
Start Date
October 13 2017
End Date
October 9 2025
Last Update
December 15 2025
Active Locations (28)
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1
Mayo Clinic Cancer Center
Scottsdale, Arizona, United States, 85259
2
Uni of Southern California
Los Angeles, California, United States, 90033
3
UCLA Jonsson Comprehensive Cancer Center
Santa Monica, California, United States, 90404
4
Columbia University Medical Center
New York, New York, United States, 10032