Investigator-Initiated Trial of Combined Ipilimumab, Nivolumab and Stereotactic Radiation in Patients With Metastatic Clear-Cell RCC (ccRCC) Who Have Failed Treatment With Single-Agent Nivolumab

Medical University of South Carolina (MUSC)

Status and phase

Withdrawn

Phase 2

Conditions

Metastatic Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Treatments

Drug: Nivolumab

Drug: Ipilimumab

Radiation: Steriotactic radiation therapy

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03149159

102576

CA209-927 (Other Grant/Funding Number)

Details and patient eligibility

About

The purpose of this study is to see if continued nivolumab with the addition of ipilimumab plus hypo-fractionated stereotactic radiation (sTR) of a single lesions results in partial or complete responses in patients with metastatic ccRCC who fail initial treatment with single agent nivolumab.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Histologically or cytologically confirmed diagnosis of metastatic ccRCC.
Age 18 years and older
ECOG 0-1
Progressive disease after treatment with single-agent nivolumab
Life expectancy at least 3 months
Presence of measurable disease per RECIST 1.1 criteria
Presence of a metastatic lesion greater than 1 cm in size that is amenable to radiation treatment
Adequate organ system function
WOCBP and men who are sexually active with WOCBP must agree to use appropriate method(s) of contraception.

Exclusion criteria

Patients are excluded if they have active brain metastases or leptomeningeal metastases (exceptions outlined in the protocol).
Active, known or suspected autoimmune disease, such as systemic lupus erythematosus, that require treatment with immune suppressing drugs.

Note: Subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger

Presence of a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone or equivalents) or other immunosuppressive medications within 14 days of study drug administration.

Note: Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.

Unstable angina or uncontrolled congestive heart failure
Uncontrolled hypercalcemia
Positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection
Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
Presence of other malignant diseases, except non-melanoma skin care
History of allergy to study drug components.
History of severe hypersensitivity reaction to any monoclonal antibody.
Anti-cancer treatment including surgery, radiotherapy, chemotherapy, other immunotherapy, or investigational therapy within 14 days of registration.
Women must not be pregnant or breastfeeding. WOCBP must have a negative serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 7 days prior to registration.
Any other medical condition for which treatment with ipilimumab or nivolumab would be medically contraindicated