A Study of Varlilumab (Anti-CD27) and Sunitinib in Patients With Metastatic Clear Cell Renal Cell Carcinoma

Trial end date:
Target enrollment:
Participant gender:
This is a study to determine the clinical benefit (how well the drug works), safety, and tolerability of combining varlilumab and sunitinib. The study will enroll patients with metastatic clear cell renal cell carcinoma.
Phase 1
Accepts Healthy Volunteers?
Lead Sponsor:
Celldex Therapeutics
Inclusion Criteria:

1. Histologically confirmed diagnosis of predominant clear cell renal cell carcinoma.

2. Advanced metastatic disease

3. Documented progressive disease based on radiographic, clinical or pathologic
assessment during or subsequent to last therapy.

4. For Phase l, no more than 3 prior anticancer regimens (IL-2 or interferon do not count
towards the total).

5. Measurable (target) disease.

6. Life expectancy ≥ 12 weeks.

7. If of childbearing potential (male or female), agrees to practice an effective form of
contraception during study treatment and for at least 70 days following last treatment

8. Must have available tumor tissue and consent to biopsy while on study.

Exclusion Criteria:

1. Prior therapy with an anti-CD27 antibody.

2. Previous treatment with sunitinib.

3. Use of any experimental immunotherapy.

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

5. 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.

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

7. 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.

8. Active, untreated central nervous system metastases.

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

10. Active diverticulitis.

11. Significant cardiovascular disease including CHF or poorly controlled hypertension.

12. Impairment of gastrointestinal function or gastrointestinal disease that may alter the
absorption of sunitinib.