Study Stopped
Due to competing trials. Stopped before IRB approval.
Combination Radiation and PD-1 Inhibition in Metastatic or Recurrent Renal Cell Carcinoma (RCC)
1 other identifier
interventional
N/A
1 country
1
Brief Summary
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.
Trial Health
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1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 9, 2016
CompletedFirst Posted
Study publicly available on registry
November 11, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 2, 2017
CompletedMarch 5, 2018
March 1, 2018
November 9, 2016
March 1, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective response rate (ORR)
Objective response rate (ORR) defined as the sum of partial response (PR) and complete response (CR). Timeframe will be best response from registration to end of treatment.
Every 3 months up to 2 years or progression
Secondary Outcomes (3)
ORR at irradiated sites
Every 3 months up to 2 years or progression
ORR at un-irradiated sites
Every 3 months up to 2 years or progression
Progression free survival (PFS)
12 months
Study Arms (1)
Nivolumab plus radiation
EXPERIMENTALNivolumab plus radiation
Interventions
240 mg per IV infusion over 60 minutes every 14 days (+/- 2 days) until disease progression or participant withdrawal from study
Radiation to at least 1 site (up to 3) of primary or metastasis, 5 fractions - delivered over 2 weeks, starting 1-3 days post-nivolumab administration. Recommended dose range is 6 Gy-12 Gy per fraction.
Eligibility Criteria
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
- +6 more criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xinglei Shen, MD
University of Kansas Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 9, 2016
First Posted
November 11, 2016
Primary Completion
February 2, 2017
Last Updated
March 5, 2018
Record last verified: 2018-03