MEDI4736 Combinations in Metastatic Renal Cell Carcinoma

Sponsor
Queen Mary University of London
Study ID
NCT02819596
Phase
PHASE2
Status
Completed

Conditions

  • Renal Clear Cell Carcinoma
  • Renal Papillary Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

This study is being carried out to see if the drugs MEDI4736, Savolitinib and Tremelimumab can be used alone or in combination to reduce the size of tumours in patients with kidney cancer. The drugs being tested in this study have an anti-tumour effect and have been tested in pre-clinical and human studies before. MEDI4736 and tremelimumab work with the immune system to help the body fight against tumour cells with immune cells. Savolitinib works to correct a faulty signal which causes tumour growth. If a patient is eligible for the study and decides to take part, they will be enrolled into one of 3 stages of the study. * First stage \[CLOSED TO RECRUITMENT\]: aims to find the optimal dose of MEDI4736+savolitinib. * Second stage \[CLOSED TO RECRUITMENT\]: patients with papillary cell cancer will be treated with MEDI4736+savolitinib. Patients with clear cell cancer will be randomised to one of four treatment arms and receive MEDI4736, savolitinib, MEDI4736+savolitinib, or MEDI4736+tremelimumab. * Third stage \[NOT YET OPEN TO RECRUITMENT\]: patients will be tested for biomarkers before enrolment, and depending on the results will be allocated to one of 2 treatments (MEDI4736 alone or MEDI4736+tremelimumab) to see if certain biomarkers are linked to drug efficacy.

Key Dates

Start date
May 3, 2016
Status verified
Nov 2024
Primary completion
Jul 17, 2024
Completion
Jul 17, 2024

Study Design

Enrollment
69 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Savolitinib
    600 mg of Savolitinib monotherapy will administered once a day until study completion or withdrawal
  • Experimental: MEDI4736
    1500 mg MEDI4736 will be administered every 4 weeks until study completion or withdrawal
  • Experimental: Savolitinib and MEDI4736
    Savolitinib and MEDI4736 will be administered at the Recommended Phase 2 dose ascertained in the phase Ib.
  • Experimental: Tremelimumab and MEDI4736
    Subjects will receive 75 mg of Tremelimumab and 1500 mg medi4736 every 4 weeks for the first four cycles, then 750 mg MEDI4736 every 4 weeks until study completion or withdrawal.

Primary Outcome Measure

Identify Dose Limiting Toxicity -Phase Ib [ Time Frame: 6 months ]