Clinical Trials Logo

Clinical Trial Summary

The primary objective of the pilot study is to determine activity of PAC-1 and nivolumab combination in subjects with metastatic renal cell carcinoma previously treated with immune checkpoint inhibitor therapy as assessed by objective response rate (ORR) using RECIST 1.1 criteria.


Clinical Trial Description

PAC-1 in combination with nivolumab: The MTD will be determined using a modified-Fibonacci dose-escalation 3+3 design.

This pilot study will evaluate nivolumab in combination with PAC-1 in subjects with metastatic RCC. Nivolumab will be delivered by IV infusion on Day 1 and PAC-1 will be taken orally on Days 1-28 of each 28-day cycle, and response will be evaluated after every 2 cycles. Treatment will continue until disease progression (based on RECIST 1.1 criteria), unacceptable toxicity, subject refusal, or subject death either from progression of disease, the therapy itself, or from other causes. Subjects who voluntarily stop the study, have progressive disease, or unacceptable toxicities will be followed for survival every 3 months for 12 months from start of study medication ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03927248
Study type Interventional
Source HealthPartners Institute
Contact
Status Withdrawn
Phase Phase 1/Phase 2
Start date September 2020
Completion date December 2021

See also
  Status Clinical Trial Phase
Completed NCT00930033 - Clinical Trial to Assess the Importance of Nephrectomy Phase 3
Recruiting NCT05863351 - Focused Radiation Versus Systemic Therapy for Kidney Cancer Patients With Limited Metastasis, SOAR Study Phase 3
Not yet recruiting NCT06284564 - A Phase II Study Bolstering Outcomes by Optimizing Immunotherapy Strategies With Evolocumab and Nivolumab in Patients With Metastatic Renal Cell Carcinoma (BOOST-RCC) Phase 2
Completed NCT00414765 - Aldesleukin in Participants With Metastatic Renal Cell Carcinoma or Metastatic Melanoma Phase 4
Active, not recruiting NCT03149822 - Study of Pembrolizumab and Cabozantinib in Patients With Metastatic Renal Cell Carcinoma Phase 1/Phase 2
Recruiting NCT03647878 - Study of Cabozantinib as Monotherapy or in Combination With Nivolumab in Patients With Advanced or Metastatic Renal Cell Carcinoma Under Real-life Clinical Setting in 1st Line Treatment.
Completed NCT01517243 - Phase II Study of Alternating Sunitinib and Temsirolimus Phase 2
Terminated NCT02122003 - Second Line Sorafenib After Pazopanib in Patients With RCC Phase 2
Completed NCT01182142 - Study of Capecitabine in Metastatic Non-clear Cell Renal Cell Carcinoma (RCC) Patients Phase 2
Completed NCT00630409 - Phase II Clinical Trial of Gemcitabine and Doxil® for Metastatic Renal Cell Carcinoma Phase 2
Recruiting NCT04140526 - Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLC Phase 1/Phase 2
Completed NCT04076787 - Clinical Outcomes for Patients With Renal Cell Carcinoma Who Received First-Line Sunitinib
Active, not recruiting NCT04467021 - Cancer and Blood Pressure Management, CARISMA Study N/A
Recruiting NCT05119335 - A Study of NKT2152, a HIF2α Inhibitor, in Patients With Advanced Clear Cell Renal Cell Carcinoma Phase 1/Phase 2
Completed NCT02282579 - Spanish Retrospective Study to Evaluate the Efficacy and Safety of Targeted Therapies After Pazopanib as First-line Therapy
Terminated NCT02071641 - Phase II Study of Sunitinib Rechallenge in Patients With Metastatic Renal Cell Carcinoma Phase 2
Completed NCT01731158 - Sequential Therapy in Metastatic Renal Cell Carinoma Phase 2
Terminated NCT01342627 - Sorafenib in Elderly Patients With Metastatic Renal Cell Carcinoma Phase 2
Active, not recruiting NCT01274273 - Study of Interleukin-2, Interferon-alpha and Bevacizumab in Metastatic Kidney Cancer Phase 2
Completed NCT00848640 - Study of Sorafenib in Patients With Advanced Renal Cell Carcinoma Phase 2