NCT04590599 is a Phase 2 clinical trial of IBI310 in Advanced Cervical Cancer, sponsored by Innovent Biologics (Suzhou) Co. Ltd..

Who is sponsoring NCT04590599?

NCT04590599 is sponsored by Innovent Biologics (Suzhou) Co. Ltd..

What drugs are being tested in NCT04590599?

Interventions in NCT04590599: IBI310, Placebo, Sintilimab.

What condition does NCT04590599 study?

NCT04590599 studies Advanced Cervical Cancer.

Is NCT04590599 still recruiting?

NCT04590599 is currently completed. Last updated 18 December 2023.

Last reviewed 2023-12-18 · How we verify

NCT04590599

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

A Phase II Clinical Study to Assess the Efficacy and Safety of IBI310 or Placebo Combined With Sintilimab for Advanced Cervical Cancer Subjects Who Have Failed or Cannot Tolerate First-line or Above Platinum-based Chemotherapy

Completed Phase 2 Last updated 18 December 2023

What this trial tests

Phase 2 trial testing IBI310 in Advanced Cervical Cancer in 205 participants. Completed in 20 November 2023.

Timeline

8 December 2020

Primary endpoint
20 November 2023

20 November 2023

Quick facts

Lead sponsor	Innovent Biologics (Suzhou) Co. Ltd.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	205
Start date	8 December 2020
Primary completion	20 November 2023
Estimated completion	20 November 2023
Sites	2 locations across China

Drugs / interventions tested

IBI310 — full drug profile →
Placebo
Sintilimab — full drug profile →

Conditions studied

Advanced Cervical Cancer — all drugs for Advanced Cervical Cancer →

Sponsor

Innovent Biologics (Suzhou) Co. Ltd. — full company profile →

Who can join

Adults 18 to 75, female only, with Advanced Cervical Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a randomized, double-blind, controlled, parallel-cohort Phase II clinical study, which is planned to enroll 220 subjects with advanced cervical cancer who have failed or cannot tolerate first-line or above platinum-based chemotherapy

Publications & conference data

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

Integration of immunotherapy into treatment of cervical cancer: Recent data and ongoing trials.
Monk BJ, Enomoto T, Kast WM, McCormack M, et al · · 2022 · cited 105× · PMID 35413489 · DOI 10.1016/j.ctrv.2022.102385
Advances in the Management of Recurrent Cervical Cancer: State of the Art and Future Perspectives.
Giudice E, Mirza MR, Lorusso D. · · 2023 · cited 7× · PMID 37870697 · DOI 10.1007/s11912-023-01463-9
IBI310 plus sintilimab vs. placebo plus sintilimab in recurrent/metastatic cervical cancer: A double-blind, randomized controlled trial.
Li H, Xu Y, Jiao X, Xu Q, et al · · 2025 · cited 3× · PMID 39827881 · DOI 10.1016/j.medj.2024.100573
Efficacy and safety of combined immune therapy for advanced cervical cancer: a systematic review and meta-analysis
Shi F, Xuan Y, Zhu Y, Wu S, et al ·
Advancements in the utilization of immune checkpoint inhibitors for the treatment of gynecological tumors.
Su Z, Zhang X, Xu J, Shen Y. · · 2026 · PMID 41983132 · DOI 10.3389/fimmu.2026.1686568
Treatment of Pelvic Recurrence After Radiotherapy for Cervical Cancer.
Song Y, Zou K, Zou L. · · 2025 · PMID 41463185 · DOI 10.3390/cancers17243934

Verify or expand the search:

Other trials of IBI310

Trials testing the same drug.

NCT07490262 — A Study to Evaluate the Efficacy and Safety of IBI310 and Sintilimab Combination Therapy in Patients With Hepatocellular · Phase 2, PHASE3 · recruiting
NCT05653180 — IBI310 in Combination With Sintilimab in Patients With Advanced Biliary Tract Cancer · Phase 1, PHASE2 · unknown
NCT05118334 — IBI310 (Anti-CTLA-4) in Combination With Sintilimab in Patients With Non-small-cell Lung Cancer (NSCLC) · Phase 1 · completed
NCT04945421 — IBI310 in Combination With Siltilimab in Subjects With Anti-PD-1/PD-L1 Resistance R/M NPC · Phase 1 · completed
NCT04868760 — A Study to Evaluate the Similarity in Pharmacokinetics and Safety of IBI310 and Ipilimumab（YERVOY）in Adult Healthy Chine · Phase 1 · completed

Other Innovent Biologics (Suzhou) Co. Ltd. trials

Trials by the same sponsor.

NCT07502534 — A Clinical Study Comparing the Bioequivalence of IBI3027 and DUPIXENT®(Dupilumab) in Healthy Chinese Volunteers · Phase 1 · not yet recruiting
NCT07469800 — Efficacy and Safety of IBI362 in Hypertensive Patients With Overweight/Obesity · Phase 3 · not yet recruiting
NCT07473960 — IBI306 Monotherapy in Non-Familial Hypercholesterolemia and Mixed Hyperlipidemia · Phase 3 · recruiting
NCT07483567 — IBI343 in Combination With Sintilimab and SOX Regimen for Perioperative Treatment of Resectable, Locally Advanced Gastri · Phase 2 · not yet recruiting
NCT07483554 — IBI343 in Combination Therapy for Advanced Malignant Solid Tumors · Phase 2 · not yet recruiting

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 NCT04590599 (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 Innovent Biologics (Suzhou) Co. Ltd.
Last refreshed: 18 December 2023

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/NCT04590599.

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