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A Study of Varlilumab (Anti-CD27) and Sunitinib in Patients With Metastatic Clear Cell Renal Cell Carcinoma

Primary Purpose

Carcinoma, Renal Cell, Kidney Diseases, Kidney Neoplasms

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Combination of varlilumab and sunitinib
Sponsored by
Celldex Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Renal Cell focused on measuring Sutent

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Histologically confirmed diagnosis of predominant clear cell renal cell carcinoma.
  2. Advanced metastatic disease
  3. Documented progressive disease based on radiographic, clinical or pathologic assessment during or subsequent to last therapy.
  4. For Phase l, no more than 3 prior anticancer regimens (IL-2 or interferon do not count towards the total).
  5. Measurable (target) disease.
  6. Life expectancy ≥ 12 weeks.
  7. If of childbearing potential (male or female), agrees to practice an effective form of contraception during study treatment and for at least 70 days following last treatment dose.
  8. Must have available tumor tissue and consent to biopsy while on study.

Exclusion Criteria:

  1. Prior therapy with an anti-CD27 antibody.
  2. Previous treatment with sunitinib.
  3. Use of any experimental immunotherapy.
  4. Chemotherapy within 21 days or at least 5 half-lives (whichever is shorter) prior to the planned start of study treatment.
  5. Systemic radiation therapy within 4 weeks, prior focal radiotherapy within 2 weeks, or radiopharmaceuticals (strontium, samarium) within 8 weeks prior to the first dose of study treatment.
  6. Use of immunosuppressive medications within 4 weeks or systemic corticosteroids within 2 weeks prior to first dose of study treatment.
  7. Other prior malignancy, except for adequately treated basal or squamous cell skin cancer or in situ cancers; or any other cancer from which the patient has been disease-free for at least 3 years.
  8. Active, untreated central nervous system metastases.
  9. Active autoimmune disease or a documented history of autoimmune disease.
  10. Active diverticulitis.
  11. Significant cardiovascular disease including CHF or poorly controlled hypertension.
  12. Impairment of gastrointestinal function or gastrointestinal disease that may alter the absorption of sunitinib.

Sites / Locations

  • University of Alabama at Birmingham
  • UC Davis Comprehensive Cancer Center
  • UCSF Helen Diller Comprehensive Cancer Center
  • George Washington University-Medical Faculty Associates
  • University of Michigan
  • Barbara Ann Karmanos Cancer Institute
  • Nebraska Cancer Specialists
  • Mount Sinai Medical Center
  • Thomas Jefferson University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Varlilumab and Sunitinib

Arm Description

Outcomes

Primary Outcome Measures

Phase 1: Safety and tolerability of varlilumab and varlilumab in combination with sunitinib as measured by incidence of drug related adverse events (AEs), serious drug related AEs, dose-limiting toxicities and laboratory test abnormalities.

Secondary Outcome Measures

Full Information

First Posted
March 6, 2015
Last Updated
July 24, 2018
Sponsor
Celldex Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT02386111
Brief Title
A Study of Varlilumab (Anti-CD27) and Sunitinib in Patients With Metastatic Clear Cell Renal Cell Carcinoma
Official Title
A Phase l/ll Study of Varlilumab in Combination With Sunitinib in Patients With Metastatic Clear Cell Renal Cell Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Terminated
Why Stopped
Portfolio re-prioritization
Study Start Date
May 2015 (undefined)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
November 3, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celldex Therapeutics

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a study to determine the clinical benefit (how well the drug works), safety, and tolerability of combining varlilumab and sunitinib. The study will enroll patients with metastatic clear cell renal cell carcinoma.
Detailed Description
Varlilumab is a fully human monoclonal antibody that binds to a molecule called CD27 found on certain immune cells and may act to promote anti-tumor effects. Sunitinib is a small molecule that inhibits multiple receptor tyrosine kinases (RTKs) some of which play a role in tumor growth and progression of cancer. This study will evaluate the safety, tolerability and efficacy of the anti-CD27 antibody varlilumab in combination with sunitinib. Eligible patients that enroll in the dose escalation portion of the study will be assigned to one of three dose levels of varlilumab in combination with 50 mg of sunitinib. The first phase of the study will test the safety profile of the combination and determine which dose of varlilumab will be studied in Phase ll* of the overall study. *Note: This Study was terminated prior to initiation of Phase II. All patients enrolled in the study will be closely monitored to determine if there is a response to the treatment as well as for any side effects that may occur.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Renal Cell, Kidney Diseases, Kidney Neoplasms, Urogenital Neoplasms, Urologic Diseases, Urologic Neoplasms, Neoplasms, Neoplasms by Histologic Type, Clear-cell Metastatic Renal Cell Carcinoma
Keywords
Sutent

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Varlilumab and Sunitinib
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Combination of varlilumab and sunitinib
Intervention Description
During the treatment phase of the study, eligible patients will receive varlilumab for up to 8 cycles. Treatment cycles are 6 weeks each with varlilumab administered once every 3 weeks and sunitinib administered daily for 4 weeks followed by a 2 week rest. There is no limit on the number of cycles of sunitinib. Patients may be discontinued from receiving study treatment (sunitinib or varlilumab) based on the results of disease assessments or if experiencing side effects that make study therapy intolerable. Phase l Dose: The planned dose of varlilumab will be dependent on the cohort assigned at enrollment. Varlilumab doses are 0.3 mg/kg, 1 mg/kg or 3 mg/kg. The Study was terminated prior to initiation of Phase II. All patients will receive sunitinib at a dose of 50 mg.
Primary Outcome Measure Information:
Title
Phase 1: Safety and tolerability of varlilumab and varlilumab in combination with sunitinib as measured by incidence of drug related adverse events (AEs), serious drug related AEs, dose-limiting toxicities and laboratory test abnormalities.
Time Frame
Safety follow-up is 100 days from last study drug dose.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed diagnosis of predominant clear cell renal cell carcinoma. Advanced metastatic disease Documented progressive disease based on radiographic, clinical or pathologic assessment during or subsequent to last therapy. For Phase l, no more than 3 prior anticancer regimens (IL-2 or interferon do not count towards the total). Measurable (target) disease. Life expectancy ≥ 12 weeks. If of childbearing potential (male or female), agrees to practice an effective form of contraception during study treatment and for at least 70 days following last treatment dose. Must have available tumor tissue and consent to biopsy while on study. Exclusion Criteria: Prior therapy with an anti-CD27 antibody. Previous treatment with sunitinib. Use of any experimental immunotherapy. Chemotherapy within 21 days or at least 5 half-lives (whichever is shorter) prior to the planned start of study treatment. Systemic radiation therapy within 4 weeks, prior focal radiotherapy within 2 weeks, or radiopharmaceuticals (strontium, samarium) within 8 weeks prior to the first dose of study treatment. Use of immunosuppressive medications within 4 weeks or systemic corticosteroids within 2 weeks prior to first dose of study treatment. Other prior malignancy, except for adequately treated basal or squamous cell skin cancer or in situ cancers; or any other cancer from which the patient has been disease-free for at least 3 years. Active, untreated central nervous system metastases. Active autoimmune disease or a documented history of autoimmune disease. Active diverticulitis. Significant cardiovascular disease including CHF or poorly controlled hypertension. Impairment of gastrointestinal function or gastrointestinal disease that may alter the absorption of sunitinib.
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
UC Davis Comprehensive Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
UCSF Helen Diller Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
George Washington University-Medical Faculty Associates
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Nebraska Cancer Specialists
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Study of Varlilumab (Anti-CD27) and Sunitinib in Patients With Metastatic Clear Cell Renal Cell Carcinoma

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