Protocol Summary

Protocol No.: OCR16016

Sponsor Protocol No.: S1609, DART

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

Principal Investigator(s)
George, Thomas

Objective
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.

Description
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.

Phase: Phase II (Cancer Control)

Age Group: Adult

Scope: National

Treatment
Treatment (nivolumab, ipilimumab)
Patients receive nivolumab 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.

Detailed Eligibility
INCLUSION CRITERIA:
1. 18 years old and older
2. Patients must have histologically confirmed rare cancer that did not have a match to a molecularly-guided therapy on EAY131 "National Cancer Institute (NCI)-Molecular Analysis for Therapy Choice (MATCH)" protocol or who progressed on molecularly-matched therapy and have no further molecularly-matched treatment recommendations per EAY131, "NCI-MATCH"
3. Patients that do not qualify for one of the histologic cohorts may be considered for registration in the "Not Otherwise Categorized" Rare Tumors cohort with confirmation of at least one of the study chairs via email
4. Patients that are determined to have a rare cancer with unknown primary site are eligible under cohort #32 (tumor of unknown primary [cancer of unknown primary; CuP]), provided that there is histologic documentation of metastatic malignancy with no discernible primary site identified from histopathologic review, physical exam and associated cross-sectional imaging of the chest, abdomen, and pelvis
5. Patients must have progressed following at least one line of standard systemic therapy and there must not be other approved/standard therapy available that has been shown to prolong overall survival (i.e. in a randomized trial against another standard treatment or by comparison to historical controls); patients who cannot receive other standard therapy that has been shown to prolonged survival due to medical issues will be eligible, if other eligibility criteria are met; OR
- Patients for whose disease no standard treatment exists that has been shown to prolong overall survival
6. Patients must have a diagnostic quality computed tomography (CT) scan or magnetic resonance imaging (MRI), performed within 28 days prior to registration, which demonstrates measurable disease, as defined in RECIST v. 1.1; all disease must be assessed and documented on the S1609 Baseline Tumor Assessment Form
7. No other prior malignancy is allowed except for the following:
- Adequately managed stage I or II cancer from which the patient is currently in complete remission
- Any other cancer from which the patient has been disease free for one year
- Adequately managed stage I or II follicular thyroid or prostate cancer is also eligible, wherein patient is not required to be in complete remission
8. Patients may have received prior anti-CTLA4 or other anti-PD-1/anti-PD-L1 therapy, not both, provided that it is completed >= 4 weeks prior to registration for monoclonal therapy, >= 8 weeks prior to registration if therapy involved immune-stimulatory monoclonal antibody (mAb)s, and >= 28 days for all other immunotherapy
9. Patients who had prior immune-related adverse event (grade 3 or higher immune-related pneumonitis, hepatitis, colitis, endocrinopathy) with prior immunotherapy (e.g. cancer vaccine, cytokine, etc.) are not eligible
10. Patients with clinically controlled thyroiditis or pituitary disorders on stable replacement therapy are eligible

** Contact study team for complete eligibility details.

Applicable Disease Sites

Brain and Nervous System
Gastrointestinal Cancer
Head & Neck Cancer
Liver Cancer
Ovarian Cancer
Sarcoma

Participating Institutions
UF Gainesville : Marlene Sarmiento

Contact
Marlene Sarmiento, RN
Phone: +1 352-265-0680 ext. 50704
Email: msarmien@ufl.edu

More Information:
View study listing on ClinicialTrials.gov
http://www.clinicaltrials.gov/ct2/show/
NCT02834013