NCT03172754

Study of Nivolumab and Axitinib in Patients With Advanced Renal Cell Carcinoma

Active, enrolled Phase 1, PHASE2 Last updated 29 October 2025

What this trial tests

Phase 1, PHASE2 trial testing Nivolumab in Renal Cell Carcinoma in 98 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

12 June 2017

Primary endpoint
6 April 2026

6 October 2026

Quick facts

Lead sponsor	Fox Chase Cancer Center
Phase	Phase 1, PHASE2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	98
Start date	12 June 2017
Primary completion	6 April 2026
Estimated completion	6 October 2026
Sites	4 locations across United States

Drugs / interventions tested

• Nivolumab (nivolumab) — full drug profile →
• Axitinib — full drug profile →

Conditions studied

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

Sponsor

Fox Chase Cancer Center — full company profile →

Who can join

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

Sponsor's own description

This is a Phase I/II, open-label, multi-center study of axitinib in combination with nivolumab in patients with previously treated and untreated advanced RCC. This clinical study will be composed of a dose finding phase (Phase I) and two parallel dose expansion phases (Phase II). The dose finding phase will assess the safety of the combination and establish a recommended phase II dose (RP2D, the highest tested dose that is declared safe and tolerable by the Investigators and the Sponsor Investigator) in patients with advanced RCC who have received prior systemic therapy for metastatic disease. Phase II will evaluate the efficacy of the combination at the RP2D in two parallel expansion cohorts in both previously treated and treatment naïve patients.

Publications & conference data

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

1. Immunotherapy in Renal Cell Carcinoma: The Future Is Now.
   Deleuze A, Saout J, Dugay F, Peyronnet B, et al · · 2020 · cited 178× · PMID 32260578 · DOI 10.3390/ijms21072532
2. Tumor Vasculatures: A New Target for Cancer Immunotherapy.
   Liu Z, Wang Y, Huang Y, Kim BYS, et al · · 2019 · cited 88× · PMID 31331639 · DOI 10.1016/j.tips.2019.07.001
3. Targeting the PD-1/PD-L1 Pathway in Renal Cell Carcinoma.
   Kammerer-Jacquet SF, Deleuze A, Saout J, Mathieu R, et al · · 2019 · cited 64× · PMID 30987368 · DOI 10.3390/ijms20071692
4. Improving antitumor immunity using antiangiogenic agents: Mechanistic insights, current progress, and clinical challenges.
   Li SJ, Chen JX, Sun ZJ. · · 2021 · cited 63× · PMID 34137513 · DOI 10.1002/cac2.12183
5. Programmed death receptor (PD-)1/PD-ligand (L)1 in urological cancers : the "all-around warrior" in immunotherapy.
   Liu Q, Guan Y, Li S. · · 2024 · cited 50× · PMID 39223527 · DOI 10.1186/s12943-024-02095-8
6. Navigating tumor angiogenesis: therapeutic perspectives and myeloid cell regulation mechanism.
   Yang F, Lee G, Fan Y. · · 2024 · cited 45× · PMID 38580870 · DOI 10.1007/s10456-024-09913-z
7. 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
8. Adverse Events of Concurrent Immune Checkpoint Inhibitors and Antiangiogenic Agents: A Systematic Review.
   Gao L, Yang X, Yi C, Zhu H. · · 2019 · cited 42× · PMID 31680957 · DOI 10.3389/fphar.2019.01173