Clinical Trials Logo
  1. Home
  2. Malignant Melanoma
  3. NCT02523313

Immunotherapy With Nivolumab or Nivolumab Plus Ipilimumab vs. Double Placebo for Stage IV Melanoma w. NED

Malignant Melanoma Clinical Trial

Official title:
A Phase II Randomized, Double-Blind Trial of Immunotherapy With Nivolumab or Nivolumab Plus Ipilimumab Versus Double-Placebo Control as a Post-Surgical/Post-Radiation Treatment for Stage IV Melanoma With No Evidence of Disease

Clinical Trial Summary

This is a prospective, double-blind placebo-controlled, multicenter, randomized phase II trial testing the adjuvant immunotherapy with Nivolumab plus Ipilimumab Placebo or Nivolumab plus Ipilimumab versus Double Placebo Control as a post-surgical/post-radiation treatment for stage IV melanoma with no evidence of disease (NED).

Clinical Trial Description

This study will allow for direct comparison of the clinical benefit provided by Nivolumab monotherapy or Nivolumab combined with Ipilimumab versus double placebo control. Furthermore, it will also allow for direct comparison of the respective safety profiles of Nivolumab monotherapy or Nivolumab combined with Ipilimumab. Nivolumab monotherapy was chosen as one of the experimental arms because of a favourable risk-benefit ratio assessed in the large Phase 1 study (MDX1106-03/CA209-003). The combination of Nivolumab and Ipilimumab was chosen as an experimental arm because of the preliminary evidence from the Phase 1 study CA209-004 suggesting synergy between Nivolumab and Ipilimumab resulting in a higher frequency of patients with increased tumour burden reduction. Evaluating both Nivolumab monotherapy and the combination of Nivolumab and Ipilimumab will provide clinical data allowing clinicians to select the appropriate treatment for each patient based on their individual risk-benefit ratio. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02523313
Study type Interventional
Source University Hospital, Essen
Contact
Status Completed
Phase Phase 2
Start date September 2, 2015
Completion date June 27, 2021
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04229277 - Fast Track Diagnosis of Skin Cancer by Advanced Imaging N/A
Completed NCT03653819 - High Intensity Interval Training (HIIT) for Patients With Cancer-related Lymphedema in the Lower Limbs N/A
Recruiting NCT04074096 - Binimetinib Encorafenib Pembrolizumab +/- Stereotactic Radiosurgery in BRAFV600 Melanoma With Brain Metastasis Phase 2
Completed NCT02935790 - Selective HDAC6 Inhibitor ACY-241 in Combination With Ipilimumab and Nivolumab Phase 1
Recruiting NCT05478876 - Carbon Ion Radiation Therapy in the Treatment of Mucous Melanomas of the Female Lower Genital Tract N/A
Completed NCT01211262 - Study to Assess the Tolerability of a Bispecific Targeted Biologic IMCgp100 in Malignant Melanoma Phase 1
Recruiting NCT03649529 - Treatment of Malignant Melanoma With GPA-TriMAR-T Cell Therapy Early Phase 1
Completed NCT03278665 - 4SC-202 in Combination With Pembrolizumab in Patients Primary Refractory/Non-responding to Prior Anti-PD-1 Therapy Phase 1/Phase 2
Completed NCT04452214 - A Study of the Safety and Tolerance of CAN04 and Pembrolizumab in Combination With and Without Carboplatin and Pemetrexed in Subjects With Solid Tumors Phase 1
Terminated NCT02709889 - Rovalpituzumab Tesirine in Delta-Like Protein 3-Expressing Advanced Solid Tumors Phase 1/Phase 2
Completed NCT01455259 - Phase I/IIa AdCD40L Immunogene Therapy for Malignant Melanoma and Other Solid Tumors Phase 1/Phase 2
Completed NCT00978913 - Transfected Dendritic Cell Based Therapy for Patients With Breast Cancer or Malignant Melanoma Phase 1
Completed NCT00232726 - Clinical Study of Previously Untreated Patients With Malignant Melanoma Phase 2
Completed NCT00336986 - Efficacy Study of IL-21 to Treat Metastatic Melanoma Phase 2
Completed NCT00350597 - GM-CSF as Adjuvant Therapy of Melanoma Phase 2
Completed NCT03545334 - Lymph Node Identification in Skin Malignancy Using ICG Transcutaneously Study N/A
Completed NCT04253574 - Comparison of PET/CT and Ultrasound in Staging of Malignant Melanoma
Completed NCT00179608 - Study of the Combination of Lenalidomide and DTIC (Dacarbazine) in Patients With Metastatic Malignant Melanoma Previously Untreated With Systemic Chemotherapy Phase 1
Terminated NCT00104884 - FR901228 in Treating Patients With Unresectable Stage III or Stage IV Malignant Melanoma Phase 2
Recruiting NCT04593485 - Anti-PD-1 Antibody in the Treatment of Patients With Malignant Melanoma of the Female Genital Tract Phase 2