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MEDI4736 Combinations in Metastatic Renal Cell Carcinoma

NCT02819596 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2024-11-04

No results posted yet for this study

Summary

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.

Conditions

  • Renal Clear Cell Carcinoma
  • Renal Papillary Cell Carcinoma

Interventions

DRUG

Savolitinib

DRUG

MEDI4736

DRUG

Tremelimumab

Sponsors & Collaborators

  • Vall d'Hebron Institute of Oncology

    collaborator OTHER

  • AstraZeneca

    collaborator INDUSTRY

  • Queen Mary University of London

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-03
Primary Completion
2024-07-17
Completion
2024-07-17

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02819596 on ClinicalTrials.gov