NCT03066427: INMUNOSUN

Study to Evaluate Efficacy and Safety of Sunitinib in Renal Cell Carcinoma Progressed to 1L Immunotherapy Treatment.

Completed Phase 2 Last updated 13 November 2020

What this trial tests

Phase 2 trial testing Sunitinib in Clear Cell Renal Carcinoma in 23 participants. Completed in 22 September 2020.

Timeline

10 May 2017

Primary endpoint
22 September 2020

22 September 2020

Quick facts

Lead sponsor	Spanish Oncology Genito-Urinary Group
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	23
Start date	10 May 2017
Primary completion	22 September 2020
Estimated completion	22 September 2020
Sites	9 locations across Spain

Drugs / interventions tested

• Sunitinib (sunitinib) — full drug profile →

Conditions studied

• Clear Cell Renal Carcinoma — all drugs for Clear Cell Renal Carcinoma →

Sponsor

Spanish Oncology Genito-Urinary Group — full company profile →

Who can join

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

Sponsor's own description

The therapeutic scenario of metastatic renal cancer is undergoing a new revolution with the appearance of a novel therapeutic strategy after the antiangiogenic treatments, that is the immunotherapy, in addition to the approval of new active drugs in the following lines of treatment.

There are currently two phase III trials in the first line of treatment in metastatic renal cancer that include different combinations of treatment based on immunotherapy. If results of these studies were positive, the therapeutic algorithm would be modified so that the remaining drugs would have to be repositioned within the therapeutic decision scheme.

Sunitinib has previously demonstrated its benefit in patients who had failed to prior treatment with cytokines, so it is likely to continue to be effective in patients who have become resistant to treatment with new drugs based on immune checkpoint blockade.

This phase II study is developed to evaluate the activity of sunitinib after treatment with immunotherapy-based regimens that are currently being developed within phase III clinical trials.

Publications & conference data

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

1. Targeting STAT3 in Cancer Immunotherapy.
   Zou S, Tong Q, Liu B, Huang W, et al · · 2020 · cited 787× · PMID 32972405 · DOI 10.1186/s12943-020-01258-7
2. Drug-Induced Hypertension Caused by Multikinase Inhibitors (Sorafenib, Sunitinib, Lenvatinib and Axitinib) in Renal Cell Carcinoma Treatment.
   Bæk Møller N, Budolfsen C, Grimm D, Krüger M, et al · · 2019 · cited 43× · PMID 31547602 · DOI 10.3390/ijms20194712
3. Targeting Tyrosine kinases in Renal Cell Carcinoma: "New Bullets against Old Guys".
   Alonso-Gordoa T, García-Bermejo ML, Grande E, Garrido P, et al · · 2019 · cited 39× · PMID 30999623 · DOI 10.3390/ijms20081901
4. STAT3 Inhibitors: A Novel Insight for Anticancer Therapy of Pancreatic Cancer.
   Li X, Jiang W, Dong S, Li W, et al · · 2022 · cited 32× · PMID 36291659 · DOI 10.3390/biom12101450
5. Predictive value of LDH kinetics in bevacizumab treatment and survival of patients with advanced NSCLC.
   Li B, Li C, Guo M, Shang S, et al · · 2018 · cited 17× · PMID 30310292 · DOI 10.2147/ott.s171566
6. Results from the INMUNOSUN-SOGUG trial: a prospective phase II study of sunitinib as a second-line therapy in patients with metastatic renal cell carcinoma after immune checkpoint-based combination therapy.
   Grande E, Alonso-Gordoa T, Reig O, Esteban E, et al · · 2022 · cited 10× · PMID 35405437 · DOI 10.1016/j.esmoop.2022.100463
7. Trimming the Vascular Tree in Tumors: Metabolic and Immune Adaptations.
   Allen E, Missiaen R, Bergers G. · · 2016 · cited 5× · PMID 28396525 · DOI 10.1101/sqb.2016.81.030940