NCT03189186

Phase-I Trial of Pembrolizumab and Percutaneous Cryoablation Combination Followed by Nephron-Sparing Surgery or Cytoreductive Nephrectomy in Locally Advanced and Metastatic Renal Cell Carcinomas

Withdrawn Phase 1 Last updated 5 April 2021

What this trial tests

Phase 1 trial testing Pembrolizumab Injection [Keytruda] in Renal Cell Carcinoma. Withdrawn.

Timeline

1 July 2017

Primary endpoint
17 October 2018

17 October 2018

Quick facts

Lead sponsor	University of California, Irvine
Phase	Phase 1
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Start date	1 July 2017
Primary completion	17 October 2018
Estimated completion	17 October 2018
Sites	1 location across United States

Drugs / interventions tested

• Pembrolizumab Injection [Keytruda] — full drug profile →
• Cryoablation — full drug profile →
• Nephrectomy

Conditions studied

• Renal Cell Carcinoma — all drugs for Renal Cell Carcinoma →
• Metastatic Kidney Cancer — all drugs for Metastatic Kidney Cancer →

Sponsor

University of California, Irvine

Who can join

Adults 18 to 99, any sex, with Renal Cell Carcinoma or Metastatic Kidney Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Patients will undergo a screening process as per standard of care to identify disease type and severity. Careful history and physical examination will also take place to rule out major heart, lung, or kidney disease and pregnancy that may affect how they will respond to the treatment. Patients with advanced (stage II and above with multiple tumors or tumors within vessels) and metastatic Renal Cell Carcinoma will be first treated with cryoablation on a large primary tumor and then given 200 mg pembrolizumab every 3-weeks 3 cycles , followed by partial/radical nephrectomy. Pembrolizumab is a biologic drug that adheres to the cell death receptors on white blood cells preventing there death and leading to an increased immunologic response. Cryoablation will be used in these patients to initially trigger and immune response to cancerous cells that is then magnified by the drug. After the surgery, patients will resume pembrolizumab for additional 5 cycles or up to a total of 2 years if a partial response is observed at the discretion of the treating medical oncologist or urologist until complete tumor remission, disease progression, unacceptable toxicity, patient refusal, or patient death due to any cause.

Publications & conference data

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

1. 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
2. PD-1/PD-L1 inhibitors-based treatment for advanced renal cell carcinoma: Mechanisms affecting efficacy and combination therapies.
   Ding L, Dong HY, Zhou TR, Wang YH, et al · · 2021 · cited 15× · PMID 34382349 · DOI 10.1002/cam4.4190
3. Radiotherapy, photodynamic therapy, and cryoablation-induced abscopal effect: Challenges and future prospects.
   Ali Mohammad S, Hak A, Pogu SV, Rengan AK. · · 2023 · cited 13× · PMID 38090387 · DOI 10.1002/cai2.53
4. Modern cancer therapy: cryoablation meets immune checkpoint blockade.
   Liu Q, Zhang C, Chen X, Han Z. · · 2024 · cited 12× · PMID 38384806 · DOI 10.3389/fonc.2024.1323070
5. Contribution of immune cells in synergistic anti-tumor effect of ablation and immunotherapy.
   He N, Jiang J. · · 2024 · cited 8× · PMID 38070356 · DOI 10.1016/j.tranon.2023.101859
6. Combining energy-based focal ablation and immune checkpoint inhibitors: preclinical research and clinical trials.
   Jiang M, Fiering S, Shao Q. · · 2023 · cited 7× · PMID 37251920 · DOI 10.3389/fonc.2023.1153066