A Phase 1b/2 Study of MEDI4736 With Tremelimumab, MEDI4736 or Tremelimumab Monotherapy in Gastric or GEJ Adenocarcinoma

  • Interventional
  • Recruiting
  • NCT02340975
Eligibility Details Visit Clinicaltrials.gov

A Phase 1b/2 Study of MEDI4736 in Combination With Tremelimumab, MEDI4736 Monotherapy, and Tremelimumab Monotherapy in Subjects With Metastatic or Recurrent Gastric or Gastroesophageal Junction Adenocarcinoma

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 subjects with metastatic or recurrent gastric or gastroesophageal junction adenocarcinoma

Gender
All

Age Group
18 Years to 99 Years

Accepting Healthy Volunteers?
No

Inclusion Criteria:

         1. Male and female subjects

         2. 18 years and older

         3. Histological or cytological confirmation of metastatic or recurrent gastric or gastroesophageal junction adenocarcinoma

         4. Subjects must have received and have progressed, or are refractory to standard regimens

         5. Subjects must have at least one lesion amenable to biospy

        Exclusion Criteria:

         1. Any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment

         2. Previous immunotherapy

         3. Concurrent or prior use of immunosuppressive medication with 14 days

         4. Active or prior documented autoimmune or inflammatory disease within 3 years with some exceptions

At a Glance

National Government IDNCT02340975

IRB#IRB15-0110

Lead SponsorMedImmune LLC

Lead PhysicianDaniel Catenacci

Collaborator(s)N/A

EligibilityAll
18 Years to 99 Years
Recruiting