Neoplasms

All Conditions

Rare Diseases

Chordoma

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Antineoplastic Agents

All Drugs and Chemicals

Nivolumab

Antibodies

Antibodies, Monoclonal

Relatlimab

Immunoglobulins

Immunoglobulin G

Immunoglobulins, Intravenous

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Immunologic Factors

Participants receive nivolumab intravenously (IV) over 60 minutes and relatlimab via infusion over 60 minutes on day 1. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

Arun Singh

This phase II trial studies how well nivolumab and relatlimab work in treating participants with chordoma that has spread to other places in the body. Monoclonal antibodies, such as nivolumab and relatlimab, may interfere with the ability of tumor cells to grow and spread.

PRIMARY OBJECTIVES:

I. To assess the clinical benefit of the combination of nivolumab and relatlimab in patients with advanced chordomas by objective response rate (ORR).

SECONDARY OBJECTIVES:

I. Ascertain the safety of nivolumab in combination with relatlimab in subjects with metastatic or locally advanced/unresectable chordoma by the frequency of adverse events (AEs).

II. Assess the clinical benefit of the combination of nivolumab and relatlimab in patients with advanced chordomas by progression free survival (PFS).

EXPLORATORY OBJECTIVES:

I. Compare response rate (RR) and clinical benefit rate (CBR) in patients whose tumors are PD-L1+ and PD-L1- at baseline.

II. Compare RR and CBR in patients whose tumors are LAG-3+ and LAG-3- at baseline.

III. In the patients who are PD-L1 positive, compare RR and CBR in patients with 1% and 5% tumor membrane staining.

III. Determine the response to treatment based on the baseline mutation load. IV. Determine the ORR and CBR via Choi criteria.

OUTLINE:

Participants receive nivolumab intravenously (IV) over 60 minutes and relatlimab via infusion over 60 minutes on day 1. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, participants are followed up within 100 days.

Nivolumab and Relatlimab in Treating Participants With Advanced Chordoma

A Signal Finding Phase 2 Study of Nivolumab (Anti-PD-1; BMS-936558; ONO-4538) and Relatlimab (Anti-LAG-3 Monoclonal Antibody; BMS-986016) in Patients With Advanced Chordoma

BOR is defined as the best response designation, as determined by the principal investigator, recorded between the date of randomization and the date of objectively documented progression per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or the date of subsequent therapy (including tumor-directed radiotherapy and tumor-directed surgery), whichever occurs first.

Bristol-Myers Squibb

Jonsson Comprehensive Cancer Center

Cetuximab

Patients receive cetuximab IV over 60-120 minutes QW in the absence of disease progression or unacceptable toxicity.

Questionnaire Administration

Anthony Conley, MD

Anthony P. Conley, MD

Anthony P Conley, MD

This is a multicenter, single arm, phase 2 study designed to evaluate the efficacy and safety of cetuximab for the treatment of advanced (unresectable)/metastatic, chordoma. The target patient population will be any chordoma patient 18 years of age with locally unresectable disease or metastatic disease.

Primary Objective:

• To evaluate the efficacy of cetuximab in patients with advanced (unresectable) or metastatic, chordoma based on response rate according to RECIST1.1.

Secondary Objectives:

* To evaluate response rate according to Choi criteria
* To evaluate the safety and tolerability of cetuximab for chordoma patients
* To evaluate the progression-free survival (median, at 24 weeks, and 52 weeks) and to determine the overall survival (median).
* To evaluate the ratio of PFS on study compared to PFS from prior treatment

Cetuximab for the Treatment of Advanced Unresectable or Metastatic Chordoma

A Phase II Trial of Cetuximab for Patients With Advanced or Metastatic Chordoma

Measured by Response Evaluation Criteria in Solid Tumors 1.1. Will be estimated based on a binomial portion expressed as percentage with 95% confidence intervals.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Nivolumab and Relatlimab in Treating Participants With Advanced Chordoma	NCT03623854	Chordoma Locally Advance... Metastatic Chor... Unresectable Ch...	Nivolumab Relatlimab	12 Years -	Jonsson Comprehensive Cancer Center
Cetuximab for the Treatment of Advanced Unresectable or Metastatic Chordoma	NCT05041127	Chordoma Metastatic Chor... Unresectable Ch...	Cetuximab Questionnaire A...	18 Years -	M.D. Anderson Cancer Center
Nivolumab and Relatlimab in Treating Participants With Advanced Chordoma	NCT03623854	Chordoma Locally Advance... Metastatic Chor... Unresectable Ch...	Nivolumab Relatlimab	12 Years -	Jonsson Comprehensive Cancer Center

Spots Global Cancer Trial Database for unresectable chordoma