Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02335918 : A Dose Escalation and Cohort Expansion Study of Anti-CD27 (Varlilumab) and Anti-PD-1 (Nivolumab) in Advanced Refractory Solid Tumors
PhasePhase 1/Phase 2
AgesMin: 18 Years Max: N/A
Eligibility
Key Inclusion Criteria:

1. Histologically-diagnosed advanced (unresectable and/or metastatic) Non-small Cell Lung
Cancer (Phase l only), Melanoma (Phase l only), Colorectal, Head and Neck SCC
(squamous cell carcinoma), Ovarian Cancer, Glioblastoma or Renal Cell Carcinoma.

- 1a. Head and Neck

Stage III/IV squamous cell carcinoma; Tumor progression or recurrence within 6 months
of last dose of platinum therapy in the adjuvant, primary, recurrent or metastatic
setting (or within 9 months if the patient received > 1 platinum-based chemotherapy
regimen in the metastatic setting). Active brain metastases or leptomeningeal
metastases are excluded; nasopharyngeal cancer, confirmed recurrent or metastatic
carcinoma of the nasopharynx and salivary gland or non-squamous histologies are also
excluded.

- 1b. Ovarian

Recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal
carcinoma requiring original or subsequent relapse histologic documentation. A
platinum-taxane based chemotherapy regimen as frontline therapy must have been
completed.

Any histologic diagnosis of borderline, low malignant potential epithelial carcinoma
are excluded.

- 1c. Colorectal Cancer -Enrollment Completed

Metastatic or recurrent; prior treatment progression during, after, or intolerant
following the last administration of approved standard therapies (required therapies
apply).

- 1d. Glioblastoma -Enrollment Completed

Have histologically confirmed World Health Organization Grade IV malignant glioma
(glioblastoma).

- Previous first line therapy with at least radiotherapy and temozolomide.

- Participants must have shown unequivocal evidence of tumor progression.

- More than one relapse, secondary glioblastoma and prior treatment with
bevacizumab are excluded.

An interval of at least 12 weeks from the completion of radiation therapy to start of
study treatment is required.

- 1e. Renal Cell Carcinoma

Have histologically confirmed diagnosis of predominant clear cell renal cell
carcinoma.

- Must have received 1 or 2 prior anti-angiogenic therapies.

- No more than 5 total previous regimens of systemic therapy, including cytokines
and cytotoxic chemotherapy.

- Disease progression during or after the last treatment regimen and within 6
months before study entry.

2. No more than 5 prior anticancer regimens for advanced (recurrent, locally advanced or
metastatic) disease except for patients with GBM which must have first recurrence of
GBM by diagnostic biopsy or contrast enhanced magnetic resonance imaging (MRI).

3. Measurable (target) disease.

4. Life expectancy ? 12 weeks.

5. If of childbearing potential (male or female), agree to practice an effective form of
contraception during study treatment and for at least 23 weeks after for female and 31
weeks after for male following last treatment dose.

Key Exclusion Criteria:

1. History of severe hypersensitivity reactions to other monoclonal antibodies.

2. Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 antibody.

3. Receipt of anti-CTLA-4 or anti-CD27 antibody within 3 months prior to the planned
start of study treatment.

4. Use of any monoclonal based therapies within 2-4 weeks prior to the first dose of
study treatment.

5. Chemotherapy within 21 days or at least 5 half-lives (whichever is shorter) prior to
the planned start of study treatment.

6. BRAF/MEK inhibitors within 2 weeks prior to the first dose of study treatment.

7. 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.

8. Use of immunosuppressive medications within 4 weeks or systemic corticosteroids within
2 weeks prior to first dose of study treatment.

9. 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.

10. Active, untreated central nervous system metastases.

11. Active autoimmune disease or a documented history of autoimmune disease

12. Active diverticulitis.

13. Interstitial lung disease that is symptomatic or may interfere with the detection or
management of suspected drug-related pulmonary toxicity.

14. Significant cardiovascular disease
LinksPermanent Link to THIS page: http://virtualtrials.com/nct/display1trial.cfm?nct=NCT02335918      |      Link to official Clinicaltrials.gov listing
Locations
Tucson, Arizona
Facility: University of Arizona Cancer Center
Investigator: Julie Bauman, MD
Contact: Julie Bauman, MD Phone: 505-272-5490
Click HERE to send email to this center

Palo Alto, California
Facility: The Stanford Center for Clinical and Translational Education and Research
Investigator: Branimir Sikic, MD
Contact: Branimir Sikic, MD Phone: 650-725-6427
Click HERE to send email to this center

Aurora, Colorado
Facility: University of Colorado Medical Center
Investigator: Antonio Jimeno, MD
Contact: Antonio Jimeno, MD Phone: 303-724-2478
Click HERE to send email to this center

New Haven, Connecticut
Facility: Smilow Cancer Hospital at Yale University Cancer Center
Investigator: Mario Sznol, MD
Contact: Matthew Madura Phone: 203-737-5381
Click HERE to send email to this center

Washington, D.C., District of Columbia
Facility: Georgetown University
Investigator: Michael Pishvaian, MD
Contact: Laura Macke, RN
Click HERE to send email to this center

Washington, D.C., District of Columbia
Facility: George Washington University School of Medicine and Health Sciences
Investigator: Jianqing Lin, MD
Contact: Jianqing Lin, MD Phone: 202-741-2981
Click HERE to send email to this center

Miami Beach, Florida
Facility: Mount Sinai Medical Center
Investigator: Jose Lutzky, MD
Contact: Jose Lutzky, MD
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Marietta, Georgia
Facility: Northwest Georgia Oncology Centers PC
Investigator: Steven McCune, MD
Contact: Steven McCune, MD Phone: 770-281-5100
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Fort Wayne, Indiana
Facility: Parkview Research Center
Investigator: Alexander Starodub, MD
Contact: Alexander Starodub, MD Phone: 260-373-8180
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Boston, Massachusetts
Facility: Dana Farber Cancer Institute
Investigator: Osama Rahma, MD
Contact: Osama Rahma, MD Phone: 617-632-6954
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Detroit, Michigan
Facility: Barbara Ann Karmanos Cancer Institute
Investigator: Amy Weise, DO
Contact: Meghan Wyse, PhD
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New York, New York
Facility: Laura and Isaac Perlmutter Cancer Center
Investigator: Daniel Cho, MD
Contact: Daniel Cho, MD Phone: 212-263-4431
Click HERE to send email to this center

New York, New York
Facility: Memorial Sloan Kettering Cancer Center
Investigator: Margaret Callahan, MD, PhD
Contact: Margaret Callahan, MD, PhD Phone: 646-888-3359
Email not avaialable

Winston-Salem, North Carolina
Facility: Wake Forest Baptist Health
Investigator: Rhonda Bitting, MD
Contact: Rhonda Bitting, MD Phone: 336-716-0327
Click HERE to send email to this center

Cleveland, Ohio
Facility: Cleveland Clinic
Investigator: Jessica Geiger, MD
Contact: Jessica Geiger, MD Phone: 216-444-0888
Click HERE to send email to this center

Portland, Oregon
Facility: Providence Health & Services
Investigator: Rachel Sanborn, MD
Contact: Tara Foote, RN BSN OCN
Click HERE to send email to this center

Fairfax, Virginia
Facility: Inova Schar Cancer Institute Research
Investigator: Jeanny Aragon-Ching, MD
Contact: Jeanny Aragon-Ching, MD Phone: 202-741-2481
Click HERE to send email to this center




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