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IRX-2 Regimen Combined With Nivolumab in Recurrent/Metastatic Solid Tumors | Clinical Trials | Clareo Health

COMPLETEDPHASE1

IRX-2 Regimen Combined With Nivolumab in Recurrent/Metastatic Solid Tumors

The IRX-2 Regimen Combined With Nivolumab in Recurrent/Metastatic Solid Tumors: A Phase 1b Study to Evaluate the Safety, Determine Recommended Phase 2 Dose (RP2D), and Investigate the Biologic and Clinical Activity

NCT03758781•H. Lee Moffitt Cancer Center and Research Institute

View on ClinicalTrials.gov

Summary

This study is to determine the safety of IRX-2 Regimen combined with Nivolumab in patients with recurrent metastatic solid tumors. Researchers believe that this combination will have a tolerable safety profile and will increase the response rate in comparison to Nivolumab alone.

Detailed Description

The first phase of this trial is to establish the safety of IRX-2 Regimen combined with Nivolumab. The IRX-2 Regimen is a 21-day regimen of cyclophosophamide on Day 1 and subcutaneous IRX-2 injections for 10 days between Days 4 and 18. If no dose limiting toxicities (DLTs) are observed during the first 4 weeks of treatment, the enrollment will continue in a dose expansion phase. If there is a study treatment related DLT in 1 of 6 patients, the same dose will be investigated at the dose expansion cohorts. If study treatment related DLT is observed in 2 of 6 patients, accrual will be stopped and new dose levels or treatment sequences will be considered.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•At least 18 years of age
•Participants must have histologically or cytologically confirmed renal cell carcinoma,urothelial carcinoma, non-small cell lung cancer, squamous cell carcinoma of the head and neck or melanoma.
•Participants must have recurrent or metastatic disease that is not amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy).
•Must be willing and able to give informed consent and adhere to protocol therapy; written informed consent and any locally required authorization must be obtained from the participant prior to performing any protocol-related procedures, including screening evaluations
•Prior exposure to PD-1/PD-L1 inhibitor monotherapy, or prior exposure to CTLA-4 inhibitor monotherapy is allowed.
•Eastern Cooperative Oncology Group (ECOG) performance status 0-2
•Adequate normal organ and marrow function
•Participants who are receiving therapeutic anti-coagulant therapy are eligible.
•Palliative radiation therapy is allowed to non-target lesions at the discretion of the treating physician.
•Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as outlined in RECIST version 1.1.
+19 more criteria

Exclusion Criteria

•Prior exposure to a combination of IRX-2 regimen, PD-1/PD-L1 inhibitors and CTLA-4 inhibitors are excluded. Prior exposure to PD-1/PD-L1 inhibitors is allowed.
•Radiation therapy with a curable intent within 30 days of first dose of study treatment is excluded. However, radiation therapy with a palliative intent is allowed to treat after 14 days from the last dose of radiation.
•Any medical contraindications or previous therapy that would preclude treatment with the IRX-2 Regimen, or nivolumab.

Locations (1)

H Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Key Dates

Start Date

February 13, 2019

Primary Completion Date

February 21, 2021

Completion Date

August 11, 2021

Last Updated

April 14, 2023

Enrollment

ACTUAL participants

Conditions

Metastatic CancerRecurrent CancerSolid TumorRenal Cell CarcinomaUrothelial CarcinomaNSCLCSquamous Cell CarcinomaNon-Small Cell Lung CancerSquamous Cell Carcinoma of the Head and Neck

Interventions

IRX 2

DRUG

Nivolumab

DRUG

A Study of PYX-201 in Advanced Solid Tumors

NCT05720117

Solid TumorAdvanced Solid Tumor

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RECRUITINGPHASE1/PHASE2

A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.

NCT06898450

Advanced Solid Tumors CancerMSI-H Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 14, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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IRX-2 Regimen Combined With Nivolumab in Recurrent/Metastatic Solid Tumors

Inclusion Criteria

Exclusion Criteria

A Study of PYX-201 in Advanced Solid Tumors

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