Phase II Trial of Nivolumab Plus Ipilimumab in Patients With Renal Medullary Carcinoma
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|ClinicalTrials.gov Identifier: NCT03274258|
Recruitment Status : Recruiting
First Posted : September 6, 2017
Last Update Posted : May 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Kidney Medullary Carcinoma Loss of INI 1 Protein Expression Stage III Renal Cell Cancer AJCC v8 Stage IV Renal Cell Cancer AJCC v8||Biological: Ipilimumab Biological: Nivolumab||Phase 2|
I. To determine the objective response rate (ORR) of patients with locally advanced or metastatic renal medullary carcinoma (RMC) treated with combination of nivolumab plus ipilimumab.
I. To determine the efficacy and safety of the combination of nivolumab plus ipilimumab in patients with RMC.
II. To evaluate potential biomarkers for patient stratification and treatment response, as well as tumor antigen-specific immune responses, such as antibody and T cell responses, as surrogates for anti-tumor activity.
Patients receive nivolumab intravenously (IV) over 60 minutes and ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive nivolumab IV over 60 minutes on day 1. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Nivolumab Plus Ipilimumab in Patients With Renal Medullary Carcinoma|
|Actual Study Start Date :||December 13, 2017|
|Estimated Primary Completion Date :||July 1, 2020|
|Estimated Study Completion Date :||July 1, 2020|
Experimental: Treatment (nivolumab, ipilimumab)
Patients receive nivolumab IV over 60 minutes and ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive nivolumab IV over 60 minutes on day 1. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
- Objective response rate (ORR) defined as completion response or partial response assessed by Response Evaluation Criteria in Solid Tumors (RECIST) criteria [ Time Frame: At 12 weeks ]Descriptive statistics will include tabulations of frequencies. The estimate of the posterior ORR and its 95% credible interval will be estimated using the same prior as utilized in the futility monitoring rules. The posterior distribution for ORR of this trial will be compared to the historical data. The Kaplan-Meier method will be utilized to display time to ORR. Association with ORR, clinical benefit rate (CBR), or toxicity (TOX) events will be explored with logistic regression.
- Progression-free survival (PFS) assessed by RECIST criteria [ Time Frame: Up to 2 years ]The Kaplan-Meier method will be utilized to display PFS.
- Incidence of adverse events [ Time Frame: Up to 2 years ]Adverse effects that will be evaluated include, but are not limited to infections, renal toxicity, hepatic toxicity, and pulmonary toxicity. Methods of assessment will include monitoring blood counts, and performing laboratory tests as indicated by clinical signs and symptoms. Evidence of toxicity or adverse events will be recorded at all clinic visits. All observed adverse effects will be graded for all patients and the degree of association of each with therapy assessed.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03274258
|Contact: Pavlos Msaouel, MDemail@example.com|
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Nizar M. Tannir 713-792-2830|
|Principal Investigator: Nizar M. Tannir|
|Principal Investigator:||Nizar M Tannir||M.D. Anderson Cancer Center|