A Phase 1 Study of MEDI4736 in Combination With Tremelimumab in Subjects With Advanced Solid Tumors

MedImmune

Status and phase: Completed; Phase 1

Conditions: Advanced Solid Tumors

Treatments: Biological: MEDI4736; Biological: tremelimumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02261220

D4190C00010

Details and patient eligibility

About

This is a multicenter, open-label, dose-exploration and dose-expansion study to evaluate the safety, tolerability, antitumor activity, PK and immunogenicity of MEDI4736 in combination with tremelimumab in subjects with select advanced solid tumors.

Enrollment: 380 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female subjects
• 18 years and older
• Histologic confirmation of advanced solid tumors
• Subjects must have recurrent/metastatic disease and may have been previously treated in the recurrent/metastatic setting.

Exclusion criteria

• Any concurrent chemotherapy, immune-mediated therapy or biologic or hormonal therapy for cancer treatment
• Active or prior documented autoimmune disease within the past 2 years
• Current or prior use of immunosuppressive medication within 14 days with some exceptions.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

380 participants in 1 patient group

MEDI4736 + Tremelimumab

Experimental group

Description:

Subjects with multiple tumor types.

Treatment:

Biological: MEDI4736

Biological: tremelimumab