NCT02626130

Tremelimumab With or Without Cryoablation in Treating Patients With Metastatic Kidney Cancer

Completed EARLY_PHASE1 Last updated 7 July 2022

What this trial tests

EARLY_PHASE1 trial testing Cryosurgery in Clear Cell Renal Cell Carcinoma in 29 participants. Completed in 20 June 2022.

Timeline

30 March 2016

Primary endpoint
20 June 2022

20 June 2022

Quick facts

Lead sponsor	M.D. Anderson Cancer Center
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	29
Start date	30 March 2016
Primary completion	20 June 2022
Estimated completion	20 June 2022
Sites	1 location across United States

Drugs / interventions tested

• Cryosurgery
• Laboratory Biomarker Analysis — full drug profile →
• Therapeutic Conventional Surgery
• Tremelimumab (TREMELIMUMAB) — full drug profile →

Conditions studied

• Clear Cell Renal Cell Carcinoma — all drugs for Clear Cell Renal Cell Carcinoma →
• Metastatic Renal Cell Cancer — all drugs for Metastatic Renal Cell Cancer →
• Stage IV Renal Cell Cancer AJCC v7 — all drugs for Stage IV Renal Cell Cancer AJCC v7 →

Sponsor

M.D. Anderson Cancer Center — full company profile →

Who can join

18 and older, any sex, with Clear Cell Renal Cell Carcinoma or Metastatic Renal Cell Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This randomized pilot clinical trial studies the side effects of tremelimumab with or without tissue cryoablation in treating patients with kidney cancer that has spread to other places in the body. Tremelimumab binds to a protein called cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), which is found on the surface of T cells (a type of white blood cell). Tremelimumab may block CTLA-4 and help the immune system kill cancer cells. Cryoablation is a procedure that uses a hollow, thin tube called a cryoprobe to freeze and destroy cancer tissue. It is not yet known whether tremelimumab with or without cryoablation is effective in treating patients with kidney cancer.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Cryoablation and immunotherapy: an overview of evidence on its synergy.
   Aarts BM, Klompenhouwer EG, Rice SL, Imani F, et al · · 2019 · cited 108× · PMID 31111237 · DOI 10.1186/s13244-019-0727-5
2. Immune Regulatory Processes of the Tumor Microenvironment under Malignant Conditions.
   Pansy K, Uhl B, Krstic J, Szmyra M, et al · · 2021 · cited 87× · PMID 34948104 · DOI 10.3390/ijms222413311
3. Cryoablation and Immunotherapy: An Enthralling Synergy to Confront the Tumors.
   Yakkala C, Chiang CL, Kandalaft L, Denys A, et al · · 2019 · cited 67× · PMID 31608067 · DOI 10.3389/fimmu.2019.02283
4. Pilot study of Tremelimumab with and without cryoablation in patients with metastatic renal cell carcinoma.
   Campbell MT, Matin SF, Tam AL, Sheth RA, et al · · 2021 · cited 52× · PMID 34737281 · DOI 10.1038/s41467-021-26415-4
5. Treatment strategies for clear cell renal cell carcinoma: Past, present and future.
   Yang J, Wang K, Yang Z. · · 2023 · cited 49× · PMID 37025584 · DOI 10.3389/fonc.2023.1133832
6. Systemic Therapies for the Management of Non-Clear Cell Renal Cell Carcinoma: What Works, What Doesn't, and What the Future Holds.
   Zoumpourlis P, Genovese G, Tannir NM, Msaouel P. · · 2021 · cited 44× · PMID 33358151 · DOI 10.1016/j.clgc.2020.11.005
7. Emerging therapeutic agents for genitourinary cancers.
   Zarrabi K, Paroya A, Wu S. · · 2019 · cited 31× · PMID 31484560 · DOI 10.1186/s13045-019-0780-z
8. Immune Checkpoint Inhibition in Advanced Non-Clear Cell Renal Cell Carcinoma: Leveraging Success from Clear Cell Histology into New Opportunities.
   Zarrabi K, Walzer E, Zibelman M. · · 2021 · cited 22× · PMID 34359554 · DOI 10.3390/cancers13153652