A Study of Varlilumab and Atezolizumab in Patients With Advanced Cancer

Stopped early · Phase 1

Conditions studied: Carcinoma, Renal Cell, Kidney Diseases, Kidney Neoplasms, Urogenital Neoplasms, Urologic Diseases, Urologic Neoplasms, Neoplasms by Histologic Type, Neoplasms, Clear-cell Metastatic Renal Cell Carcinoma, Melanoma, Triple Negative Breast Cancer, Bladder Cancer, Head and Neck Cancer, Non-small Cell Lung Cancer

In brief

This is a study to determine the clinical benefit (how well the drug works), safety and tolerability of combining varlilumab and atezolizumab. Phase l of the study will enroll patients with a number of tumor types; Phase ll will enroll only patients with renal cell carcinoma (RCC).\* \*Note: This Study was terminated prior to initiation of Phase II

Key facts

Study ID

NCT02543645

Run by

Celldex Therapeutics

People needed

18

Starts

2015-10-01

Expected to finish

2017-05-22

Last updated by the study team

2018-04-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Unresectable stage lll or IV, histologically confirmed diagnosis of one of the following solid tumors:
• Phase l: Melanoma, RCC, triple negative breast cancer, bladder cancer, head and neck cancer or non-small cell lung cancer.
• Documented progressive disease based on radiographic, clinical or pathologic assessment during or subsequent to last therapy.
• Progressed or intolerant to at least 1 approved prior anticancer regimen.
• Measurable (target) disease.
• Life expectancy ≥ 12 weeks.
• If of childbearing potential (male or female), agrees to practice an effective form of contraception during study treatment and for at least 90 days following last treatment dose.
• Must have available tumor tissue and consent to biopsy while on study.
• Patients with asymptomatic treated CNS metastasis may be enrolled after discussion with the Medical Monitor.
• ECOG of 0 or 1.

You may not qualify if…

• Prior therapy with varlilumab or with an anti-CD27 antibody.
• Previous treatment with anti-PD-1, anti-PD-L1 or anti-PD-L2 therapy.
• Use of any experimental immunotherapy.
• Receipt of anti-CTLA-4 targeted therapies or other checkpoint or co-stimulatory therapy within 3 months prior to start of study treatment.
• Chemotherapy within 21 days or at least 5 half-lives (whichever is shorter) prior to the planned state of study treatment.
• 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.
• Use of immunosuppressive medications within 4 weeks or systemic corticosteroids within 2 weeks prior to first dose of study treatment.
• 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.
• Active, untreated CNS metastases.
• Active autoimmune disease or a documented history of autoimmune disease.
• Active diverticulitis.
• Significant cardiovascular disease including CHF, leptomeningeal disease, poorly controlled hypertension, or an MI within 6 months prior to dosing.
• Known alcohol or drug abuse.

Where it is running

• University of California - San Francisco — San Francisco, California, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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