NCT02917772 (TITAN-RCC) is a Phase 2 clinical trial of Nivolumab/Ipilimumab in Carcinoma, Renal Cell, sponsored by AIO-Studien-gGmbH.

Who is sponsoring NCT02917772?

NCT02917772 is sponsored by AIO-Studien-gGmbH.

What drugs are being tested in NCT02917772?

Interventions in NCT02917772: Nivolumab/Ipilimumab.

What condition does NCT02917772 study?

NCT02917772 studies Carcinoma, Renal Cell, Clear-cell Metastatic Renal Cell Carcinoma.

Is NCT02917772 still recruiting?

NCT02917772 is currently completed. Last updated 5 October 2022.

Last reviewed 2022-10-05 · How we verify

NCT02917772: TITAN-RCC

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Phase II Single Arm Clinical Trial of a Tailored ImmunoTherapy Approach With Nivolumab in Subjects With Metastatic or Advanced Renal Cell Carcinoma

Completed Phase 2 Last updated 5 October 2022

What this trial tests

Phase 2 trial testing Nivolumab/Ipilimumab in Carcinoma, Renal Cell in 200 participants. Completed in 1 October 2022.

Timeline

1 October 2016

Primary endpoint
1 October 2021

1 October 2022

Quick facts

Lead sponsor	AIO-Studien-gGmbH
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	200
Start date	1 October 2016
Primary completion	1 October 2021
Estimated completion	1 October 2022
Sites	35 locations across Austria, Belgium, Czechia, France, Germany, Italy, Spain, United Kingdom

Drugs / interventions tested

Nivolumab/Ipilimumab

Conditions studied

Carcinoma, Renal Cell — all drugs for Carcinoma, Renal Cell →
Clear-cell Metastatic Renal Cell Carcinoma — all drugs for Clear-cell Metastatic Renal Cell Carcinoma →

Sponsor

AIO-Studien-gGmbH — full company profile →

Who can join

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

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Objective Response Rate (ORR)
Time frame: until 30 weeks after last patient first treatment, LPFT
(RECIST 1.1) by CT or MRI measured at week 8 (+/- 1 week) and week 16 (+/- 1 week), 28 (+/- 1 week) and then every 12 weeks (+/- 1 week). The primary objective will be measured by the primary endpoint of ORR (based on investigator assessments) among all treated subjects, first line subjects and second line subjects. It is defined as the number of subjects with a best overall response of CR or PR

Sponsor's own description

TITAN RCC (0216-ASG) is a Phase 2, open-label study of nivolumab monotherapy with additional nivolumab/ipilimumab "boost" cycles in previously untreated and pretreated (2nd line), advanced or metastatic renal cell carcinoma (mRCC) subjects with intermediate and high risk disease according to IMDC.

Publications & conference data

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

Myeloid-derived suppressor cells as immunosuppressive regulators and therapeutic targets in cancer.
Li K, Shi H, Zhang B, Ou X, et al · · 2021 · cited 687× · PMID 34620838 · DOI 10.1038/s41392-021-00670-9
Optimized Management of Nivolumab and Ipilimumab in Advanced Renal Cell Carcinoma: A Response-Based Phase II Study (OMNIVORE).
McKay RR, McGregor BA, Xie W, Braun DA, et al · · 2020 · cited 82× · PMID 33108238 · DOI 10.1200/jco.20.02295
Myeloid-Derived Suppressor Cells in Solid Tumors.
Ma T, Renz BW, Ilmer M, Koch D, et al · · 2022 · cited 77× · PMID 35053426 · DOI 10.3390/cells11020310
New treatment options for metastatic renal cell carcinoma with prior anti-angiogenesis therapy.
Zarrabi K, Fang C, Wu S. · · 2017 · cited 64× · PMID 28153029 · DOI 10.1186/s13045-016-0374-y
Dosing Regimens of Immune Checkpoint Inhibitors: Attempts at Lower Dose, Less Frequency, Shorter Course.
Jiang M, Hu Y, Lin G, Chen C. · · 2022 · cited 36× · PMID 35795044 · DOI 10.3389/fonc.2022.906251
Combination therapy with PD-1/PD-L1 blockade: An overview of ongoing clinical trials.
Johnson CB, Win SY. · · 2018 · cited 26× · PMID 29632719 · DOI 10.1080/2162402x.2017.1408744
Tailored immunotherapy approach with nivolumab with or without nivolumab plus ipilimumab as immunotherapeutic boost in patients with metastatic renal cell carcinoma (TITAN-RCC): a multicentre, single-arm, phase 2 trial.
Grimm MO, Esteban E, Barthélémy P, Schmidinger M, et al · · 2023 · cited 25× · PMID 37844597 · DOI 10.1016/s1470-2045(23)00449-7
From Bench to Bedside: How the Tumor Microenvironment Is Impacting the Future of Immunotherapy for Renal Cell Carcinoma.
Anker J, Miller J, Taylor N, Kyprianou N, et al · · 2021 · cited 19× · PMID 34831452 · DOI 10.3390/cells10113231

Verify or expand the search:

Other trials of Nivolumab/Ipilimumab

Trials testing the same drug.

NCT03219775 — Tailored ImmunoTherapy Approach With Nivolumab in Subjects With Metastatic or Advanced Transitional Cell Carcinoma · Phase 2 · unknown
NCT03065179 — SBRT (Stereotactic Body Radiation Therapy) in Combination With Nivolumab/Ipilimumab in Renal Cell Carcinoma (RCC) / Kidn · Phase 2 · completed

Other recruiting trials for Carcinoma, Renal Cell

Currently open trials in the same condition.

NCT07405164 — Extension Study for Participants in Studies That Include Belzutifan (MK-6482-043/LITESPARK-043) · Phase 3 · recruiting
NCT07227415 — Symbiotic-GU-08: A Study to Learn About the Medicine Called PF-08634404 Dosed Alone and in Combination With Other Antica · Phase 1, PHASE2 · recruiting
NCT06222593 — Study to Evaluate the Safety and Efficacy of Bicalutamide in Combination With Sunitinib in Patients With TKIs-resistant · Phase 1, PHASE2 · recruiting
NCT07166445 — Deep Learning for Automated Discrimination Between Stage T1-T2 and T3 Renal Cell Carcinoma on Contrast-Enhanced CT · recruiting
NCT06676527 — Vorolanib in the Second-line Treatment of Patients With Unresectable or Metastatic Renal Cell Carcinoma · recruiting

Other AIO-Studien-gGmbH trials

Trials by the same sponsor.

NCT05510895 — Neoadjuvant Encorafenib, Binimetinib and Cetuximab for Patients With BRAF V600E Mutated/pMMR Localized Colorectal Cancer · Phase 2 · completed
NCT05190263 — Quality Assurance on Anemia Management in Patients With Solid Tumors and Malignant Lymphoma · completed
NCT04727541 — Neoadjuvant Bintrafusp Alfa in Patients With Resectable Biliary Tract Cancer · Phase 2 · terminated
NCT04172467 — Quality Assurance of Secondary Immunodeficiencies (SID) in CLL/MM Patients · completed
NCT04221529 — Patients With ES-SCLC and ECOG PS=2 Receiving Atezolizumab-Carboplatin-Etoposide · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02917772 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AIO-Studien-gGmbH
Last refreshed: 5 October 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02917772.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing