Neoadjuvant MEDI 4736 +/- Tremelimumab in Locally Advanced Renal Cell Carcinoma

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
Moshe Ornstein
Study ID
NCT02762006
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Durvalumab — DRUG
    Durvalumab is a programmed cell death ligand-1 monoclonal antibody which has demonstrated anti-tumor efficacy renal cell carcinoma and other malignancies via activation of the immune system.
  • Tremelimumab — DRUG
    Tremelimumab is a CTLA-4 monoclonal antibody.

Study Details

The purpose of this study is to investigate the safety and feasibility of administering investigational drugs (meaning not Food and Drug Administration (FDA)-approved for kidney cancer) prior to surgical treatment for kidney cancer. The first drug is called MEDI4736, and the second drug is called tremelimumab. Both of these drugs work by attaching to certain proteins on immune cells with the goal of stimulating an immune response against cancer cells. This is a phase 1 trial, with the primary goal of identifying if this treatment is safe and possible side effects when given prior to surgery for kidney cancer.

Key Dates

Start date
Dec 20, 2016
Status verified
Mar 2024
Primary completion
Nov 6, 2020
Completion
Nov 6, 2020

Study Design

Enrollment
29 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Durvalumab + Tremelimumab with Nephrectomy
    Following systemic therapy, patients will undergo nephrectomy. Adjuvant therapy will be administered within 4-6 weeks of surgery. Subsequent follow-up will then be completed to assess adverse event resolution and long-term outcomes. * Cohort 1: Durvalumab x 1 dose (n=6) * Cohort 2: Durvalumab + Tremelimumab x 1 dose (n=6) * Cohort 2a: Durvalumab + Tremelimumab x 1 dose (n=12) * Cohort 3: Durvalumab + Tremelimumab x 1 dose (n=9) Cohorts 1 and 2: Adjuvant dosing of Durvalumab x 1 beginning 2-8 weeks after surgery. Cohort 2a: Durvalumab monotherapy until 1 year after nephrectomy. Cohort 3: Adjuvant dosing of durvalumab + tremelimumab x 1 beginning 2-8 weeks after surgery, then durvalumab monotherapy until 1 year after nephrectomy.

Primary Outcome Measure

Patients with Dose Limiting Toxicity (DTL) [ Time Frame: Up to 12 months after screening ]

Locations (2)

FacilityCityStateZIPSite coordinators
University of MinnesotaMinneapolisMinnesota55455-
Cleveland Clinic, Case Comprehensive Cancer CenterClevelandOhio44195-

Find similar trials in Minneapolis, MN

By condition
Kidney cancer
By specialty
OncologyUrology
By research site
University of Minnesota· Minneapolis, MNCleveland Clinic, Case Comprehensive Cancer Center· Cleveland, OH

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