← Back to Search

Checkpoint Inhibitor

Tremelimumab for Renal Cell Carcinoma

Phase < 1
Waitlist Available
Led By Padmanee Sharma
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This study is evaluating whether tremelimumab with or without cryoablation is safe and effective in treating patients with kidney cancer.

Eligible Conditions
  • Renal Cell Carcinoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03
Incidence of extreme toxicities as graded by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03
Secondary outcome measures
Changes in indication markers
Longitudinal data on immunological values over time
Progression free survival
+1 more

Side effects data

From 2019 Phase 2 trial • 33 Patients • NCT03007407
38%
Fatigue
21%
Diarrhea
17%
Pruritus
17%
Maculopapular rash
17%
Anorexia
17%
Nausea
17%
Fever
14%
Rash maculo-papular
14%
Constipation
10%
Itching
10%
Anemia
10%
Abdominal pain
7%
Cough
7%
Dry Skin
7%
Dehydration
7%
Hypothyroidism
7%
Non-cardiac chest pain
7%
Weight loss
100%
80%
60%
40%
20%
0%
Study treatment Arm
Durvalumab and Tremelimumab

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm B (tremelimumab and cryoablation)Experimental Treatment4 Interventions
Patients undergo cryoablation and receive tremelimumab IV over 60 minutes at weeks 1 (2-6 days after cryoablation) and 5. Within 4-6 weeks later, patients undergo surgery or biopsy. After surgery or biopsy, patients receive tremelimumab IV Q34W for 3 doses, and then Q12W in the absence of disease progression or unacceptable toxicity.
Group II: Arm A (tremelimumab)Experimental Treatment3 Interventions
Patients receive tremelimumab IV over 60 minutes at weeks 1 and 5. Within 4-6 weeks later, patients undergo surgery or biopsy. After surgery or biopsy, patients receive tremelimumab IV Q4W for 3 doses, and then every Q12W in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cryosurgery
2015
Completed Phase 4
~540
Therapeutic Conventional Surgery
2005
Completed Phase 3
~9850
Tremelimumab
2017
Completed Phase 2
~3380

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,973 Previous Clinical Trials
1,789,292 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,664 Previous Clinical Trials
40,926,104 Total Patients Enrolled
Padmanee SharmaPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
104 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Tremelimumab With or Without Cryoablation in Treating Patients With Metastatic Kidney Cancer
2016. "Tremelimumab With or Without Cryoablation in Treating Patients With Metastatic Kidney Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02626130.
~3 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top