Combination Radiation and PD-1 Inhibition in Metastatic or Recurrent Renal Cell Carcinoma (RCC)

Withdrawn before enrolling · Phase 2

Conditions studied: Carcinoma, Renal Cell

In brief

There are two primary aims in the study: 1) to determine the tolerability and feasibility of combination hypofractionated radiation therapy and PD-1 inhibition with nivolumab, and 2) to determine the ability of hypofractionated radiation therapy to enhance response rate from PD-1 inhibition versus PD-1 inhibition alone by comparing the observed response rate under the combination therapy with a previously reported response rate under inhibition alone.

Key facts

Study ID

NCT02962804

Run by

University of Kansas Medical Center

People needed

0

Last updated by the study team

2018-03-05

Who can join

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

You may qualify if…

• Histologically confirmed history of renal cell carcinoma (all variants are acceptable)
• Progression or recurrence after at least one prior tyrosine kinase inhibitor therapy including, but not limited to: sunitinib, pazopanib, axitinib.
• At least 1 site (primary or metastasis) amenable to hypofractionated radiation therapy and appropriate for radiation therapy as part of standard of care per medical, urologic or radiation oncologist discretion. NOTE: CT / MRI imaging to have been completed no more than 30 days before enrollment on study.
• Potential indications for radiation therapy include (but are not limited to):
• Painful bone or soft tissue metastasis
• Symptoms from mass effect caused by tumor
• Prevention of impending symptoms from tumor
• Hemoptysis due to tumor
• Limited oligometastasis
• Isolated region of progression
• Patients with prior IL-2 treatment are eligible
• At least 14 days since any prior therapy
• Eastern Cooperative Oncology Group (ECOG) performance status 0 - 3
• Adequate organ and marrow function as defined below:
• leukocytes ≥ 2,000/mcL
• absolute neutrophil count ≥ 1,000/mcL
• platelets ≥ 100,000/mcL
• total bilirubin within normal institutional limits
• AST(SGOT) ≤ 2.5 X institutional upper limit of normal
• ALT(SPGT) ≤ 2.5 X institutional upper limit of normal
• Women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception. Men of child-bearing potential must not donate sperm while on this study and for 90 days after their last study treatment.

You may not qualify if…

• Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
• Men who are trying to father a child.
• Presence of a condition or abnormality that in the opinion of the study-delegated investigator would compromise the safety of the patient or the quality of the data.
• Requirement for high dose steroids: dexamethasone > 2 mg per day or equivalent
• NOTE: Per OPDIVO (Nivolumab) package insert, no formal pharmacokinetic drug-drug interaction studies have been conducted with OPDIVO (Nivolumab) - therefore, no other concomitant medications will exclude potential participants.
• Life expectancy < 6 months.
• Other active malignancy (patients with no evidence of disease (NED) or are in remission are eligible).
• Patient has untreated brain metastases. Patients are eligible after documented stable or improved brain metastases at least 1 month after treatment of brain metastases.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to PD-1 Inhibitors used in study.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Patients with active, known or suspected autoimmune disease (not including type 1 diabetes mellitus, hypothyroidism, skin disorders not requiring systemic treatment or conditions not expected to recur).
• Patients with interstitial lung disease
• Patients receiving concurrent other cancer-directed therapy including, but not limited to, Tyrosine Kinase Inhibitor (TKI), Mammalian Target Of Rapamycin (mTOR) inhibition and/or chemotherapy.

Where it is running

• University of Kansas Medical Center — Kansas City, Kansas, United States

Full record on ClinicalTrials.gov

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