Clinical Trial Finder

A Dose Escalation and Cohort Expansion Study of Anti-CD27 (Varlilumab) and Anti-PD-1 (Nivolumab) in Advanced Refractory Solid Tumors

Study Purpose

This is a study to determine the clinical benefit (how well the drug works), safety, and tolerability of combining varlilumab and nivolumab (also known as Opdivo® , BMS-936558). Both drugs target the immune system and may act to promote anti-cancer effects.

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Study Type
Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT02335918

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase
Phase 1/Phase 2

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
Celldex Therapeutics

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
Celldex Therapeutics
Principal Investigator Affiliation N/A

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
IndustryIndustry
Overall Status Recruiting
Countries United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Squamous Cell Carcinoma of the Head and Neck (SCCHN), Ovarian Carcinoma-Enrollment Completed, Colorectal Cancer (CRC)-Enrollment Completed, Renal Cell Carcinoma (RCC) (Phase ll Only), Glioblastoma (GBM) (Phase ll Only)-Enrollment Completed
Additional Details

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. Nivolumab is a fully human monoclonal antibody that binds to a molecule called PD-1 on immune cells and promotes anti-tumor effects. 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 3 mg/kg of nivolumab. The first phase of the study will test the safety profile of the combination and determine which dose will be studied in Phase ll of the overall study. During Phase ll, depending on cancer type, groups of patients will be enrolled and receive varlilumab at a dose of either 3 mg/kg every 2 weeks, 3 mg/kg every 12 weeks, or 0.3 mg/kg every 4 weeks in combination with nivolumab at 240 mg. All patients enrolled in the study will be closely monitored to determine if there is response to the treatment as well as for any side effects that may occur.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Arizona Cancer Center, Tucson, Arizona

Status

Recruiting

Address

University of Arizona Cancer Center

Tucson, Arizona, 85719

Site Contact

Julie Bauman, MD

jebauman@email.arizona.edu

505-272-5490

Palo Alto, California

Status

Recruiting

Address

The Stanford Center for Clinical and Translational Education and Research

Palo Alto, California, 94304

Site Contact

Branimir Sikic, MD

brandy@stanford.edu

650-725-6427

San Francisco, California

Status

Recruiting

Address

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94115

Site Contact

Alain Algazi, MD

alain.algazi@ucsf.edu

415-502-3081

University of Colorado Medical Center, Aurora, Colorado

Status

Recruiting

Address

University of Colorado Medical Center

Aurora, Colorado, 80045

Site Contact

Antonio Jimeno, MD

antonio.jimeno@ucdenver.edu

303-724-2478

New Haven, Connecticut

Status

Recruiting

Address

Smilow Cancer Hospital at Yale University Cancer Center

New Haven, Connecticut, 06519

Site Contact

Matthew Madura

matthew.madura@yale.edu

203-737-5381

Georgetown University, Washington, District of Columbia

Status

Recruiting

Address

Georgetown University

Washington, District of Columbia, 20007

Site Contact

Laura Macke, RN

LAB228@georgetown.edu

Washington, District of Columbia

Status

Recruiting

Address

George Washington University School of Medicine and Health Sciences

Washington, District of Columbia, 20037

Site Contact

Jianqing Lin, MD

jilin@mfa.gwu.edu

202-741-2981

Mount Sinai Medical Center, Miami Beach, Florida

Status

Recruiting

Address

Mount Sinai Medical Center

Miami Beach, Florida, 33140

Site Contact

Jose Lutzky, MD

jose.lutzky@msmc.com

Atlanta, Georgia

Status

Withdrawn

Address

The Winship Cancer Institute, Emory University

Atlanta, Georgia, 30322

Northwest Georgia Oncology Centers PC, Marietta, Georgia

Status

Recruiting

Address

Northwest Georgia Oncology Centers PC

Marietta, Georgia, 30060

Site Contact

Steven McCune, MD

smcune@ngoc.com

770-281-5100

Parkview Research Center, Fort Wayne, Indiana

Status

Recruiting

Address

Parkview Research Center

Fort Wayne, Indiana, 46845

Site Contact

Alexander Starodub, MD

Alexander.Starodub@parkview.com

260-373-8180

Dana Farber Cancer Institute, Boston, Massachusetts

Status

Recruiting

Address

Dana Farber Cancer Institute

Boston, Massachusetts, 02115

Site Contact

Osama Rahma, MD

Osamae_rahma@DFCI.harvard.edu

617-632-6954

Barbara Ann Karmanos Cancer Institute, Detroit, Michigan

Status

Recruiting

Address

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201

Site Contact

Meghan Wyse, PhD

wysem@karmanos.org

Laura and Isaac Perlmutter Cancer Center, New York, New York

Status

Recruiting

Address

Laura and Isaac Perlmutter Cancer Center

New York, New York, 10016

Site Contact

Daniel Cho, MD

daniel.cho@nyumc.org

212-263-4431

Columbia University Medical Center, New York, New York

Status

Active, not recruiting

Address

Columbia University Medical Center

New York, New York, 10032

Memorial Sloan Kettering Cancer Center, New York, New York

Status

Recruiting

Address

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

Site Contact

Margaret Callahan, MD, PhD

646-888-3359

Wake Forest Baptist Health, Winston-Salem, North Carolina

Status

Recruiting

Address

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157

Site Contact

Rhonda Bitting, MD

rbitting@wakehealth.edu

336-716-0327

Cleveland Clinic, Cleveland, Ohio

Status

Recruiting

Address

Cleveland Clinic

Cleveland, Ohio, 44195

Site Contact

Jessica Geiger, MD

geigerj@ccf.org

216-444-0888

Providence Health & Services, Portland, Oregon

Status

Recruiting

Address

Providence Health & Services

Portland, Oregon, 97213

Site Contact

Tara Foote, RN BSN OCN

tara.foote@providence.org

Inova Schar Cancer Institute Research, Fairfax, Virginia

Status

Recruiting

Address

Inova Schar Cancer Institute Research

Fairfax, Virginia, 22031

Site Contact

Jeanny Aragon-Ching, MD

Jeanny.Aragon-ching@inova.org

202-741-2481

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