Clinical Trials Logo
  1. Home
  2. Other
  3. NCT03274258

Phase II Trial of Nivolumab Plus Ipilimumab in Patients With Renal Medullary Carcinoma

Stage IV Renal Cell Cancer AJCC v8 Clinical Trial

Official title:
Phase II Trial of Nivolumab Plus Ipilimumab in Patients With Renal Medullary Carcinoma

Clinical Trial Summary

This phase II trial studies how well nivolumab and ipilimumab work in treating patients with kidney cancer. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Clinical Trial Description

PRIMARY OBJECTIVES: 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. SECONDARY OBJECTIVES: 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. OUTLINE: 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03274258
Study type Interventional
Source M.D. Anderson Cancer Center
Contact
Status Active, not recruiting
Phase Phase 2
Start date December 13, 2017
Completion date July 31, 2025
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05863351 - Focused Radiation Versus Systemic Therapy for Kidney Cancer Patients With Limited Metastasis, SOAR Study Phase 3
Recruiting NCT06049576 - Nivolumab and Ipilimumab With and Without Camu Camu for the Treatment of Patients With Metastatic Renal Cell Carcinoma Phase 1
Active, not recruiting NCT04467021 - Cancer and Blood Pressure Management, CARISMA Study N/A
Withdrawn NCT04603365 - Pamiparib and Temozolomide for the Treatment of Hereditary Leiomyomatosis and Renal Cell Cancer Phase 2
Recruiting NCT05112627 - Immunophenotyping in Metastatic Kidney Cancer Patients Receiving Ablative Therapy
Active, not recruiting NCT04514484 - Testing the Combination of the Anti-cancer Drugs XL184 (Cabozantinib) and Nivolumab in Patients With Advanced Cancer and HIV Phase 1
Active, not recruiting NCT05122546 - CBM588 in Combination With Nivolumab and Cabozantinib for the Treatment of Advanced or Metastatic Kidney Cancer Phase 1
Not yet recruiting NCT06391099 - Ketogenic Dietary Intervention to Improve Response to Immunotherapy in Patients With Metastatic Melanoma and Metastatic Kidney Cancer N/A
Active, not recruiting NCT04904302 - Sitravatinib and Nivolumab for the Treatment of Metastatic or Advanced Clear Cell Renal Cell Cancer Phase 2
Active, not recruiting NCT03473730 - Daratumumab in Treating Patients With Muscle Invasive Bladder Cancer or Metastatic Kidney Cancer Early Phase 1
Active, not recruiting NCT03541902 - Cabozantinib or Sunitinib Malate in Treating Participants With Metastatic Variant Histology Renal Cell Carcinoma Phase 2
Active, not recruiting NCT03829111 - CBM588, Nivolumab, and Ipilimumab in Treating Patients With Stage IV or Advanced Kidney Cancer Phase 1
Recruiting NCT03866382 - Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors Phase 2
Recruiting NCT04510597 - Comparing the Outcome of Immunotherapy-Based Drug Combination Therapy With or Without Surgery to Remove the Kidney in Metastatic Kidney Cancer, the PROBE Trial Phase 3
Recruiting NCT05269381 - Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab for Treatment of Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT05411081 - Testing Cabozantinib With or Without Atezolizumab in Patients With Advanced Papillary Kidney Cancer, PAPMET2 Trial Phase 2
Recruiting NCT04693377 - Cryoablation Combined With Stereotactic Body Radiation Therapy for the Treatment of Painful Bone Metastases, the CROME Trial N/A
Recruiting NCT06265285 - Comparison of In-Home Versus In-Clinic Administration of Subcutaneous Nivolumab Through Cancer CARE (Connected Access and Remote Expertise) Beyond Walls (CCBW) Program Phase 2
Active, not recruiting NCT03793166 - Immunotherapy With Nivolumab and Ipilimumab Followed by Nivolumab or Nivolumab With Cabozantinib for Patients With Advanced Kidney Cancer, The PDIGREE Study Phase 3
Recruiting NCT05327686 - Testing the Addition of Stereotactic Radiation Therapy With Immune Therapy for the Treatment of Patients With Unresectable or Metastatic Renal Cell Cancer, SAMURAI Study Phase 2