Phase 2
N=113
A Phase 1b/2 Study of MEDI4736 With Tremelimumab, MEDI4736 or Tremelimumab Monotherapy in Gastric or GEJ Adenocarcinoma
Gastric or Gastroesophageal Junction Adenocarcinoma
Bottom Line
View on ClinicalTrials.gov: NCT02340975 ↗Enrolled (actual)
113
Serious AEs
61.1%
Results posted
May 2020
Primary outcome: Primary: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) in Phase 1b — 6; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- MEDI4736 + tremelimumab (Biological); MEDI4736 (Biological); Tremelimumab (Biological); MEDI4736+tremelimumab (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- MedImmune LLC
- Primary completion
- Apr 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) in Phase 1b |
6; 2 | — |
| PRIMARY Number of Participants With Dose Limiting Toxicities (DLTs) in Phase 1b |
1 | — |
| PRIMARY Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Phase 1b |
1; 1; 1; 1; 1; 1 | — |
| PRIMARY Number of Participants With Abnormal Vital Signs and Physical Examinations Reported as TEAEs in Phase 1b |
1; 1 | — |
| PRIMARY Number of Participants With Abnormal Electrocardiograms Reported as TEAEs in Phase 1b |
1 | — |
| PRIMARY Eastern Cooperative Oncology Group (ECOG) Performance Status at Baseline in Phase 1b |
4; 2 | — |
| PRIMARY Percentage of Participants With Objective Response (OR) in Phase 2 |
11.1; 0; 8.3; 4.0; 15.8 | 0.2376 |
| PRIMARY Progression Free Survival at 6 (PFS-6) Month in Phase 2 |
12.1; NA; 23.3; 12.5; 5.3 | — |
| SECONDARY Percentage of Participants With Objective Response in Phase 1b |
— | — |
| SECONDARY Duration of Stable Disease (DSD) in Phase 1b |
5.4 | — |
| SECONDARY Median Best Percentage Change From Baseline of the Sum of Longest Diameters (SLD) of Target Lesions in Phase 1b |
17.7 | — |
| SECONDARY Percentage of Participants With Disease Control at 16 Weeks in Phase 1b |
33.3 | — |
| SECONDARY Percentage of Participants With Disease Control at 24 Weeks in Phase 1b |
16.7 | — |
| SECONDARY Progression Free Survival at 6 Month in Phase 1b |
16.7 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) in Phase 2 |
27; 23; 12; 22; 18; 14 | — |
| SECONDARY Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Phase 2 |
9; 3; 3; 7; 4; 1 | — |
| SECONDARY Number of Participants With Abnormal Vital Signs and Physical Examinations Reported as TEAEs in Phase 2 |
1; 1; 1; 0; 0; 0 | — |
| SECONDARY Number of Participants With Abnormal Electrocardiograms Reported as TEAEs in Phase 2 |
3; 1; 0; 0; 0; 1 | — |
| SECONDARY Eastern Cooperative Oncology Group (ECOG) Performance Status at Baseline in Phase 2 |
9; 9; 4; 11; 11; 18 | — |
| SECONDARY Percentage of Participants With Disease Control at 16 Weeks in Phase 2 |
18.5; 12.5; 16.7; 28.0; 21.1 | — |
| SECONDARY Percentage of Participants With Disease Control at 24 Weeks in Phase 2 |
11.1; 0; 16.7; 12.0; 15.8 | — |
| SECONDARY Duration of Response (DoR) in Phase 2 |
NA; 4.6; 7.4; 3.1 | — |
| SECONDARY Time to Response (TTR) in Phase 2 |
1.9; 2.7; 7.2; 1.8 | — |
| SECONDARY Duration of Stable Disease in Phase 2 |
3.5; 3.6; 7.7; 4.2; 3.5 | — |
| SECONDARY Median Best Percentage Change From Baseline of the Sum of Longest Diameters (SLD) of Target Lesions in Phase 2 |
8.00; 21.20; -4.00; 0.00; 3.00 | — |
| SECONDARY Progression Free Survival in Phase 2 |
1.8; 1.6; 1.7; 1.8; 1.8 | — |
| SECONDARY Progression Free Survival at 9 Month (PFS-9) in Phase 2 |
12.1; NA; NA; 4.2; 5.3 | — |
| SECONDARY Overall Survival (OS) in Phase 2 |
9.2; 3.4; 7.7; 10.7; 7.0 | — |
| SECONDARY Overall Survival at 12 Months in Phase 2 |
37.0; NA; 13.1; 40.7; 29.2 | — |
| SECONDARY Percentage of Participants With Objective Response With Positive Interferon Gamma (IFN-γ) Gene Expression in Phase 2 |
15.8 | — |
| SECONDARY Percentage of Participants With Progression Free Survival (PFS) at 6 Month With Positive IFN-γ Gene Expression in Phase 2 |
5.3 | — |
| SECONDARY Percentage of Participants With Objective Response in Phase 2 by Programmed Death-ligand (PD-L1) Status |
13.3; 0; 0; 0; 33.3; 11.1 | — |
Summary
This is a randomized, multicenter, open-label, dose-exploration and dose-expansion study to evaluate the safety, tolerability, antitumor activity, PK, pharmacodynamics, and immunogenicity of MEDI4736 in combination with tremelimumab, MEDI4736 monotherapy or tremelimumab monotherapy in participants with metastatic or recurrent gastric or gastroesophageal junction adenocarcinoma.
Eligibility Criteria
Inclusion Criteria
- Male and female participants
- 18 years and older
- Histological or cytological confirmation of metastatic or recurrent gastric or gastroesophageal junction adenocarcinoma
- Participants must have received and have progressed, or are refractory to standard regimens
- Participants must have at least one lesion amenable to biospy
Exclusion Criteria
- Any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment
- Previous immunotherapy
- Concurrent or prior use of immunosuppressive medication with 14 days
- Active or prior documented autoimmune or inflammatory disease within 3 years with some exceptions
Data sourced from ClinicalTrials.gov (NCT02340975). 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.