Low-Dose-Rate Brachytherapy Combined With Immune Checkpoint Inhibition in Cancer

Renal Cell Cancer Clinical Trial

Official title:

Low-Dose-Rate Brachytherapy Combined With Immune Checkpoint Inhibition in Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04620603
• Other study ID #: CASE6620
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: May 27, 2021
• Est. completion date: March 1, 2025

Study information

• Verified date: June 2024
• Source: Case Comprehensive Cancer Center
• Contact: Jay Ciezki, MD
• Phone: 1-866-223-8100
• Email: TaussigResearch[@]ccf.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a pilot study of combination low dose rate brachytherapy (LDR) added to standard of care (SOC) immunotherapy in stage III and IV melanoma, stage IV renal call cancer, and stage IV urothelial cancer.

Description:

The purpose of this study is to evaluate the effect of combining LDR with immune checkpoint inhibition in stage III and IV melanoma, stage IV renal call cancer, and stage IV urothelial cancer. This involves the addition of a treatment called brachytherapy to SOC immunotherapy. Brachytherapy is a form of radiation therapy where radioactive pellets are placed within a tumor to temporarily irradiate the tumor at a low level. This is the first time that this combination (immunotherapy and brachytherapy) has been used in humans.

The objectives of this study are to evaluate the effect of combining LDR with immunotherapy, determine safety and feasibility, generate a toxicity profile, evaluate response, and overall survival.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: March 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participants must have histologically confirmed unresectable stage III or stage IV cutaneous melanoma, stage IV renal cell cancer, and stage IV urothelial cancer.

• ECOG performance status 0-2.

• Have measurable disease per RECIST v1.1 or iRECIST. Refer to Appendix B

• Have the following clinical laboratory values:

• Absolute neutrophil count (ANC) = 1500/ µL

• Hgb = 9 g/dL

• Platelet count = 75, 000/ µL

• Total bilirubin = 1.5 x ULN (upper limit of normal)

• AST and ALT = 2x ULN

• Serum Creatinine < 2x ULN

• Female participants who:

• Are postmenopausal for at least 1 year before entering the screening visit, OR

• Are surgically sterile, OR

• Agree to practice true abstinence from heterosexual contact or agree to use effective contraception without interruption during the study therapy and 90 days after the last dose.

• Male participants who:

• Are surgically sterile, OR

• Agree to practice true abstinence from heterosexual contact or agree to use effective contraception without interruption during the study therapy and 90 days after the last dose.

Exclusion Criteria:

• Participants diagnosed with mucosal or uveal melanoma

• Participants who have been treated with whole head radiation for brain metastases

• Invasive cancers diagnosed < 3 years prior that required systemic treatment.

• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

• Prior anti-cancer therapy for melanoma, renal cell cancer, or urothelial cancer less than 14 days prior to first dose of study treatment.

• Pregnant or nursing females

• Unwilling or unable to follow protocol requirements.

• Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive study treatment.

• Other active non-melanoma, non-renal cell, or non-urothelial metastatic cancers requiring systemic treatment.

• Participants currently receiving systemic corticosteroids doses over 15mg prednisone or equivalent.

• Participants with uncontrolled HIV or hepatitis.

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Cutaneous Malignant Melanoma
• Melanoma
• Renal Cell Cancer

Intervention

Radiation:
• Low Dose Rate Brachytherapy (LDR)
LDR on treatment day 1

Drug:
• Standard-of-Care Immunotherapy
Standard or care immunotherapy will be administered at the FDA approved dose via IV infusion.

Locations

Country	Name	City	State
United States	Cleveland Clinic, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with tumor response assessed by Immunotherapy Response Evaluation Criteria in Solid Tumors (iRECIST)	iRECIST was developed by the RECIST working group for the use of RECIST version 1.1 in cancer immunotherapy trials, to ensure consistent design and data collection.; ORR is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on iRECIST or RECIST v1.1 at any time during the study. CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions, progressive disease (PD) is >20% increase in sum of diameters of target lesions, stable disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions. Estimation based on CT or MRI scans	3 months after brachytherapy
Primary	Number of participants with tumor response assessed by Immunotherapy Response Evaluation Criteria in Solid Tumors (iRECIST)	iRECIST was developed by the RECIST working group for the use of RECIST version 1.1 in cancer immunotherapy trials, to ensure consistent design and data collection.; ORR is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on iRECIST or RECIST v1.1 at any time during the study. CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions, progressive disease (PD) is >20% increase in sum of diameters of target lesions, stable disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions. Estimation based on CT or MRI scans	6 months after brachytherapy
Primary	Number of participants with tumor response assessed by Immunotherapy Response Evaluation Criteria in Solid Tumors (iRECIST)	iRECIST was developed by the RECIST working group for the use of RECIST version 1.1 in cancer immunotherapy trials, to ensure consistent design and data collection.; ORR is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on iRECIST or RECIST v1.1 at any time during the study. CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions, progressive disease (PD) is >20% increase in sum of diameters of target lesions, stable disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions. Estimation based on CT or MRI scans	9 months after brachytherapy
Primary	Number of participants with tumor response assessed by Immunotherapy Response Evaluation Criteria in Solid Tumors (iRECIST)	iRECIST was developed by the RECIST working group for the use of RECIST version 1.1 in cancer immunotherapy trials, to ensure consistent design and data collection.; ORR is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on iRECIST or RECIST v1.1 at any time during the study. CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions, progressive disease (PD) is >20% increase in sum of diameters of target lesions, stable disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions. Estimation based on CT or MRI scans	12 months after brachytherapy
Primary	Number of participants with tumor response assessed by RECIST v1.1	ORR is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on the Response Evaluation Criteria in Solid Tumors (iRECIST or RECIST v1.1) at any time during the study. CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions, progressive disease (PD) is >20% increase in sum of diameters of target lesions, stable disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions. Estimation based on CT or MRI scans	3 months after brachytherapy
Primary	Number of participants with tumor response assessed by RECIST v1.1	ORR is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on iRECIST or RECIST v1.1 at any time during the study. CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions, progressive disease (PD) is >20% increase in sum of diameters of target lesions, stable disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions. Estimation based on CT or MRI scans	6 months after brachytherapy
Primary	Number of participants with tumor response assessed by RECIST v1.1	ORR is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on iRECIST or RECIST v1.1 at any time during the study. CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions, progressive disease (PD) is >20% increase in sum of diameters of target lesions, stable disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions. Estimation based on CT or MRI scans	9 months after brachytherapy
Primary	Number of participants with tumor response assessed by RECIST v1.1	ORR is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on iRECIST or RECIST v1.1 at any time during the study. CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions, progressive disease (PD) is >20% increase in sum of diameters of target lesions, stable disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions. Estimation based on CT or MRI scans	12 months after brachytherapy