Clinical Trials Logo

Clinical Trial Summary

The purpose of this study is to find out if the administration of Interleukin-2 concurrently with ipilimumab followed by Nivolumab will result in improved anti-cancer activity and if it is effective for advanced melanoma.

Clinical Trial Description

This is a Phase II study of high dose bolus interleukin-2 (HD IL2) in combination with low dose ipilimumab followed sequentially by nivolumab in patients with advanced inoperable stage III or stage IV melanoma who have failed prior anti-PD1 immunotherapy. The planned treatment consists of up to 3 courses (One cycle is 21 days and one course is 4 cycles). HD IL2 will be given during week 1 of the 2 initial cycles or each course. Ipilimumab will be given concurrently at the low dose of 1 mg/kg on Day 1 of the 2 initial cycles of each course for up to 2 doses, total. Nivolumab will be given on Day 1 of the 3rd cycle of each course. No systemic treatment will be administered during the 4th cycle. Response assessment will occur at the end of the 4th cycle. Patients without evidence of disease progression (RECIST v.1.1) or limiting toxicities will be offered additional courses of treatment for up to a maximum of 3 courses, total ;

Study Design

Related Conditions & MeSH terms

NCT number NCT04562129
Study type Interventional
Source H. Lee Moffitt Cancer Center and Research Institute
Contact Leticia Tetth
Phone 813-745-4617
Status Recruiting
Phase Phase 2
Start date September 24, 2020
Completion date September 2029

See also
  Status Clinical Trial Phase
Active, not recruiting NCT04330430 - Neo-adjuvant T-VEC + Nivolumab Combination Therapy for Resectable Early Metastatic (Stage IIIB/C/D-IV M1a) Melanoma With Injectable Disease Phase 2
Withdrawn NCT04007588 - A Phase II Trial of Neoadjuvant Treatment With PD-1 Inhibition (Nivolumab) With or Without IDO Inhibition (BMS-986205) and With or Without CTLA-4 Inhibition (Ipilimumab) in Resectable Stage III or IV Melanoma Phase 2
Recruiting NCT05171374 - pRospective Evaluation of Clinical Outcomes in Patients With metAsTatIс melanOma Treated With dabrafeNib and trAmetinib in reaL practicE
Completed NCT03620019 - Denosumab + PD-1 in Subjects With Stage III/ IV Melanoma Phase 2
Recruiting NCT04990726 - Immune Related Toxicity and Symptom Burden in Chronic Cancer Survivors With Melanoma Receiving Adjuvant Immunotherapy With Immune Checkpoint Inhibitors
Recruiting NCT05970497 - A Study Assessing KB707 for the Treatment of Locally Advanced or Metastatic Solid Tumors Phase 1
Recruiting NCT05370807 - A Clinical Trial of Regorafenib in Patients With Pretreated Advanced Melanoma Phase 2
Recruiting NCT04045691 - Binimetinib Plus Encorafenib Real Life Investigation of Next Generation Melanoma Treatment
Not yet recruiting NCT05068453 - Study of Oncolytic Virus in Combination With HX-008 and Radiotherapy in Melanoma Patients With Liver Metastasis Phase 1
Not yet recruiting NCT05070221 - Study of Oncolytic Virus in Combination With HX-008 and Axitinib in Melanoma Patients With Liver Metastasis Phase 1
Recruiting NCT03353402 - Fecal Microbiota Transplantation (FMT) in Metastatic Melanoma Patients Who Failed Immunotherapy Phase 1
Recruiting NCT04513028 - Beta Glucan's Effect on Pembrolizumab Immunologic Response in Stage III-IV Melanoma N/A
Recruiting NCT05598853 - Intrathecal Double Checkpoint Inhibition Phase 1
Recruiting NCT04521075 - A Phase Ib Trial to Evaluate the Safety and Efficacy of FMT and Nivolumab in Subjects With Metastatic or Inoperable Melanoma, MSI-H, dMMR or NSCLC Phase 1/Phase 2
Completed NCT03153085 - A Study of Combination With TBI-1401(HF10) and Ipilimumab in Japanese Patients With Unresectable or Metastatic Melanoma Phase 2
Recruiting NCT04741997 - Adjuvant Therapy Based on Pathologic Response After Neoadjuvant Encorafenib Binimetinib in Melanoma Early Phase 1
Recruiting NCT03991130 - High Dose IL-2 in Combination With Anti-PD-1 to Overcome Anti-PD-1 Resistance in Metastatic Melanoma and Renal Cell Carcinoma Phase 2
Not yet recruiting NCT06425926 - Safety and Tolerability Study of GIM-531 in Advanced Solid Tumors Phase 1/Phase 2
Active, not recruiting NCT04526899 - Trial With BNT111 and Cemiplimab in Combination or as Single Agents in Patients With Anti-PD-1-refractory/Relapsed, Unresectable Stage III or IV Melanoma Phase 2
Recruiting NCT06319196 - Clear Me: Interception Trial to Detect and Clear Molecular Residual Disease in Patients With High-risk Melanoma Phase 2