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

NCT02386111 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2018-07-26

No results posted yet for this study

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.

Conditions

  • Carcinoma, Renal Cell
  • Kidney Diseases
  • Kidney Neoplasms
  • Urogenital Neoplasms
  • Urologic Diseases
  • Urologic Neoplasms
  • Neoplasms
  • Neoplasms by Histologic Type
  • Clear-cell Metastatic Renal Cell Carcinoma

Interventions

DRUG

Combination of varlilumab and sunitinib

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.

Sponsors & Collaborators

  • Celldex Therapeutics

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2017-08-31
Completion
2017-11-03

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT02386111 on ClinicalTrials.gov