Clinical Trials Logo
  1. Home
  2. Advanced Melanoma
  3. NCT04495257

A Study of APX005M in Combination With Nivolumab and Ipilimumab in Treatment Naïve Patients With Advanced Melanoma or Renal Cell Carcinoma (RCC)

Renal Cell Carcinoma Clinical Trial

Official title:
A Phase I Study of APX005M in Combination With Nivolumab and Ipilimumab in Treatment Naïve Patients With Advanced Melanoma or Renal Cell Carcinoma

Clinical Trial Summary

This study is a Phase 1, open-label, single institution, dose escalation and dose expansion study to evaluate the efficacy, safety, and tolerability of APX005M in combination with nivolumab and ipilimumab in patients with advanced melanoma and RCC.

Clinical Trial Description

This trial is a phase 1 study to evaluate the safety and tolerability of APX005M in combination with nivolumab and ipilimumab. The study will enroll patients with advanced solid tumors (melanoma, RCC) to determine the recommended phase II dosing (RP2D) of APX005M in combination with ipilimumab 1mg/kg and nivolumab 3 mg/kg (IPI1 NIVO3) every 3 weeks for four cycles followed by APX005M in combination with nivolumab 360mg every 3 weeks. APX005M will be administered at a dose of 0.1 mg/kg every 3 weeks in Dose Level 1 (DL1) and escalated to 0.3 mg/kg every 3 weeks in Dose Level 2 (DL2) (Table 1). The IPI1 NIVO3 regimen is approved for patients with metastatic RCC. APX005M is a humanized IgG1 agonistic monoclonal antibody that binds CD40. Nivolumab is a humanized IgG4 monoclonal antibody directed against PD-1. Ipilimumab is a humanized IgG1κ monoclonal antibody directed against CTLA-4. Primary Objective - To assess the safety and tolerability of APX005M in combination with nivolumab and ipilimumab - To determine the recommended RP2D of APX005M in combination with nivolumab and ipilimumab in patients with unresectable metastatic melanoma or renal cell carcinoma. Secondary Objective • Determine rate and pattern of AEs in patients treated with APX005M in combination with nivolumab and ipilimumab ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04495257
Study type Interventional
Source Yale University
Contact
Status Active, not recruiting
Phase Phase 1
Start date September 14, 2020
Completion date February 2025
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04987203 - Study to Compare Tivozanib in Combination With Nivolumab to Tivozanib Monotherapy in Subjects With Renal Cell Carcinoma Phase 3
Recruiting NCT06391879 - Establishment of a Multidimensional Prediction Model for the Natural Course of VHL Disease-related Renal Cell Carcinoma
Completed NCT02526017 - Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers Phase 1
Recruiting NCT05059444 - ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation
Terminated NCT03655613 - APL-501 or Nivolumab in Combination With APL-101 in Locally Advanced or Metastatic HCC and RCC Phase 1/Phase 2
Active, not recruiting NCT03170960 - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Withdrawn NCT05418387 - A Social Support Intervention to Improve Treatment Among Hispanic Kidney and Liver Cancer Patients in Arizona N/A
Recruiting NCT04623502 - An Investigation of Kidney and Urothelial Tumor Metabolism in Patients Undergoing Surgical Resection and/or Biopsy N/A
Completed NCT02853344 - Study of Pembrolizumab (MK-3475) Monotherapy in Locally Advanced/Metastatic Renal Cell Carcinoma (MK-3475-427/KEYNOTE-427) Phase 2
Terminated NCT04088500 - A Study of Combination Nivolumab and Ipilimumab Retreatment in Patients With Advanced Renal Cell Carcinoma Phase 2
Completed NCT05070637 - Circulating Tumor Cell Reducing No-touch Nephrectomy N/A
Active, not recruiting NCT03634540 - A Trial of Belzutifan (PT2977, MK-6482) in Combination With Cabozantinib in Patients With Clear Cell Renal Cell Carcinoma (ccRCC) (MK-6482-003) Phase 2
Not yet recruiting NCT06049030 - A Study of HS-10516 in Patients With Advanced Clear Cell Renal Cell Carcinoma Phase 1
Completed NCT03652077 - A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies Phase 1
Completed NCT01358721 - Phase I Biomarker Study (BMS-936558) Phase 1
Active, not recruiting NCT04503148 - Anesthesia and Cancer Study: Renal Cell Carcinoma N/A
Completed NCT02386826 - INC280 Combined With Bevacizumab in Patients With Glioblastoma Multiforme Phase 1
Not yet recruiting NCT05808608 - A Study of AK104 Plus Axitinib in Advanced/Metastatic Special Pathological Subtypes of Renal Cell Carcinoma Phase 1/Phase 2
Withdrawn NCT03323710 - Study of Propranolol Plus Sunitinib in First-line Treatment of Metastatic Renal Cell Carcinoma Phase 2
Not yet recruiting NCT02787915 - DC1s-CTL Cellular Therapy for Renal Cell Carcinoma Phase 1/Phase 2