Neoadjuvant Nivolumab+Ipilimumab Followed by Adjuvant Nivolumab or

Status Withdrawn

Clinical Trial Summary

The purpose of this study is to evaluate the role of neoadjuvant immunotherapy and to demonstrate high pathologic complete response (pCR) and near pCR rates in melanoma participants with clinically detectable nodal disease and a high risk of recurrence. Neoadjuvant immunotherapy aims to enhance the systemic T-cell response to tumor antigens while detectable tumor is still present, inducing a stronger and broader tumor-specific immune response. Of the neoadjuvant approaches studied within melanoma, the neoadjuvant combination of nivolumab and ipilimumab has demonstrated high pCR and near pCR rates that may translate to prolonged clinical benefit.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Melanoma

Clinical Trial Details

NCT number	NCT04495010
Study type	Interventional
Source	Bristol-Myers Squibb
Contact
Status	Withdrawn
Phase	Phase 2
Start date	March 31, 2021
Completion date	October 23, 2027

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05094804` - A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents	Phase 1/Phase 2
Completed	`NCT03979872` - Risk Information and Skin-cancer Education for Undergraduate Prevention	N/A
Recruiting	`NCT04986748` - Using QPOP to Predict Treatment for Sarcomas and Melanomas
Enrolling by invitation	`NCT00068003` - Harvesting Cells for Experimental Cancer Treatments
Recruiting	`NCT05707286` - Pilot Study to Determine Pro-Inflammatory Cytokine Kinetics During Immune Checkpoint Inhibitor Therapy
Active, not recruiting	`NCT05470283` - Phase I, Open-Label, Study of Tumor Infiltrating Lymphocytes Engineered With Membrane Bound IL15 Plus Acetazolamide in Adult Patients With Metastatic Melanoma	Phase 1
Recruiting	`NCT05077137` - A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy	Phase 1
Active, not recruiting	`NCT02721459` - XL888 + Vemurafenib + Cobimetinib for Unresectable BRAF Mutated Stage III/IV Melanoma	Phase 1
Completed	`NCT00341939` - Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
Recruiting	`NCT05839912` - Excision of Lymph Node Trial (EXCILYNT) (Mel69)	N/A
Recruiting	`NCT04971499` - A Study of Dapansutrile Plus Pembrolizumab in Patients With PD-1 Refractory Advanced Melanoma	Phase 1/Phase 2
Recruiting	`NCT05263453` - HL-085+Vemurafenib to Treat Advanced Melanoma Patients With BRAF V600E/K Mutation	Phase 2
Active, not recruiting	`NCT05060432` - Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors	Phase 1/Phase 2
Not yet recruiting	`NCT06413680` - A First-In Human (FIH) Trial to Find Out if REGN10597 is Safe and How Well it Works for Adult Participants With Advanced Solid Organ Malignancies	Phase 1/Phase 2
Completed	`NCT03348891` - TNF in Melanoma Patients Treated With Immunotherapy	N/A
Terminated	`NCT03399448` - NY-ESO-1-redirected CRISPR (TCRendo and PD1) Edited T Cells (NYCE T Cells)	Phase 1
Completed	`NCT03171064` - Exercise as a Supportive Measure for Patients Undergoing Checkpoint-inhibitor Treatment	Phase 2
Not yet recruiting	`NCT05539118` - Interferon-α1b Combined With Toripalimab and Anlotinib Hydrochloride in Advanced Unresectable Melanoma	Phase 1/Phase 2
Recruiting	`NCT05171374` - pRospective Evaluation of Clinical Outcomes in Patients With metAsTatIс melanOma Treated With dabrafeNib and trAmetinib in reaL practicE
Withdrawn	`NCT02854488` - Yervoy Pregnancy Surveillance Study

Neoadjuvant Nivolumab+Ipilimumab Followed by Adjuvant Nivolumab or Neoadjuvant Nivolumab+Ipilimumab Followed by Adjuvant Observation Compared With Adjuvant Nivolumab in Treatment-Naive High-risk Melanoma Participants — CheckMate 7UA

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms