NCT02210117

Nivolumab With or Without Bevacizumab or Ipilimumab Before Surgery in Treating Patients With Metastatic Kidney Cancer That Can Be Removed by Surgery

Active, enrolled EARLY_PHASE1 Last updated 7 January 2026

What this trial tests

EARLY_PHASE1 trial testing Bevacizumab in Clear Cell Renal Cell Carcinoma in 104 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

25 November 2014

Primary endpoint
30 November 2026

30 November 2026

Quick facts

Lead sponsor	M.D. Anderson Cancer Center
Phase	EARLY_PHASE1
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	104
Start date	25 November 2014
Primary completion	30 November 2026
Estimated completion	30 November 2026
Sites	1 location across United States

Drugs / interventions tested

• Bevacizumab (Bevacizumab-Bvzr) — full drug profile →
• Biopsy
• Ipilimumab — full drug profile →
• Laboratory Biomarker Analysis
• Metastasectomy
• Nivolumab (nivolumab) — full drug profile →
• Therapeutic Conventional Surgery

Conditions studied

• Clear Cell Renal Cell Carcinoma — all drugs for Clear Cell Renal Cell Carcinoma →
• Metastatic Kidney Carcinoma — all drugs for Metastatic Kidney Carcinoma →
• 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 Kidney Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This randomized pilot early phase I trial studies the side effects and how well nivolumab alone works compared to nivolumab with bevacizumab or ipilimumab before surgery in treating patients with kidney cancer, also referred to as renal cell cancer, that has spread to another place in body and can be removed by surgery. Immunotherapy with monoclonal antibodies, such as nivolumab, bevacizumab, and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Publications & conference data

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

1. Molecular and cellular insights into T cell exhaustion.
   Wherry EJ, Kurachi M. · · 2015 · cited 3643× · PMID 26205583 · DOI 10.1038/nri3862
2. B cells and tertiary lymphoid structures promote immunotherapy response.
   Helmink BA, Reddy SM, Gao J, Zhang S, et al · · 2020 · cited 2093× · PMID 31942075 · DOI 10.1038/s41586-019-1922-8
3. Synergistic effect of immune checkpoint blockade and anti-angiogenesis in cancer treatment.
   Yi M, Jiao D, Qin S, Chu Q, et al · · 2019 · cited 487× · PMID 30925919 · DOI 10.1186/s12943-019-0974-6
4. Therapeutic antitumor immunity by checkpoint blockade is enhanced by ibrutinib, an inhibitor of both BTK and ITK.
   Sagiv-Barfi I, Kohrt HE, Czerwinski DK, Ng PP, et al · · 2015 · cited 344× · PMID 25730880 · DOI 10.1073/pnas.1500712112
5. Anti-angiogenic Agents in Combination With Immune Checkpoint Inhibitors: A Promising Strategy for Cancer Treatment.
   Song Y, Fu Y, Xie Q, Zhu B, et al · · 2020 · cited 198× · PMID 32983126 · DOI 10.3389/fimmu.2020.01956
6. Inhibition of Immune Checkpoints and Vascular Endothelial Growth Factor as Combination Therapy for Metastatic Melanoma: An Overview of Rationale, Preclinical Evidence, and Initial Clinical Data.
   Ott PA, Hodi FS, Buchbinder EI. · · 2015 · cited 184× · PMID 26442214 · DOI 10.3389/fonc.2015.00202
7. The Role of the Tumor Vasculature in the Host Immune Response: Implications for Therapeutic Strategies Targeting the Tumor Microenvironment.
   Hendry SA, Farnsworth RH, Solomon B, Achen MG, et al · · 2016 · cited 150× · PMID 28066431 · DOI 10.3389/fimmu.2016.00621
8. Cytotoxic T lymphocyte antigen-4 and immune checkpoint blockade.
   Buchbinder E, Hodi FS. · · 2015 · cited 130× · PMID 26325034 · DOI 10.1172/jci80012