Clinical Trial: Nivolumab and Ipilimumab in Treating Patients With Rare Tumors

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: DART: Dual Anti-CTLA-4 and Anti-PD-1 Blockade in Rare Tumors

Brief Summary: This clinical trial studies nivolumab and ipilimumab in treating patients with rare tumors. Monoclonal antibodies, such as nivolumab and ipilimumab, may interfere with the ability of tumor cells to grow and spread.

Detailed Summary:

PRIMARY OBJECTIVES:

I. To evaluate the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 overall response rate (ORR) in subsets of patients with advanced rare cancers treated with ipilimumab plus nivolumab combination immunotherapy.

SECONDARY OBJECTIVES:

I. To evaluate toxicities in each cohort. II. To estimate overall survival (OS), progression-free survival (PFS), clinical benefit rate; and to estimate immune-related ORR (irORR), and immune-related PFS (irPFS) by unidimensional immune-related response criteria.

III. To collect specimens for banking for use in future correlative biomarker research studies.

OUTLINE:

Patients receive nivolumab intravenously (IV) over 30 minutes on days 1, 15, and 29 and ipilimumab IV over 60 minutes on day 1. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 10 years from registration.


Sponsor: National Cancer Institute (NCI)

Current Primary Outcome: ORR defined as confirmed and unconfirmed complete and partial response, assessed by RECIST 1.1 [ Time Frame: Up to 10 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Best response calculated from the sequence of RECIST 1.1 and immune-related response criteria (irRC) objectives [ Time Frame: Up to 10 years ]
    Assuming 16 eligible patients per stratum, this will be sufficient to estimate each binary version of this endpoint within +/- 25% (95% confidence interval).
  • Clinical benefit rate defined as complete response, partial response, or stable disease, estimated using both RECIST and irRC [ Time Frame: 6 months ]
    Assuming 16 eligible patients per stratum, this will be sufficient to estimate each binary version of this endpoint within +/- 25% (95% confidence interval).
  • Incidence of adverse events graded by NCI CTCAE version 4.0 [ Time Frame: Up to 10 years ]
    Assuming 16 eligible patients per stratum, this will be sufficient to estimate each binary version of this endpoint within +/- 25% (95% confidence interval).
  • OS, estimated using both RECIST and irRC [ Time Frame: From date of registration to date of death due to any cause, assessed up to 10 years ]
    Assuming 16 eligible patients per stratum, this will be sufficient to estimate each binary version of this endpoint within +/- 25% (95% confidence interval).
  • PFS, estimated using both RECIST and irRC [ Time Frame: From date of registration to date of first documentation of progression or symptomatic deterioration or death, assessed up to 10 years ]
    Assuming 16 eligible patients per stratum, this will be sufficient to estimate each binary version of this endpoint within +/- 25% (95% confidence interval).


Original Secondary Outcome: Same as current

Information By: National Cancer Institute (NCI)

Dates:
Date Received: July 13, 2016
Date Started: January 2017
Date Completion:
Last Updated: May 26, 2017
Last Verified: May 2017