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Table 3 Ongoing Phase III clinical trials in cervical cancer

From: Cervical cancer heterogeneity: a constant battle against viruses and drugs

Trial identifier

Brief title

Estimated Enrollment

Criteria

Arms and Interventions

Primary outcome measures [Time Frame]

Estimated Study Completion Date

NCT02422563

Neoadjuvant chemotherapy followed by radical

hysterectomy (op) versus primary

chemo-radiation in cervical cancer FIGO stage

IB2 and IIB

534

IB2, IIB

Arm I: NACT + Radical hysterectomy

Arm II: CCRT

DFS

[5 years]

October 2025

NCT02629718

Neoadjuvant chemotherapy + surgery versus

surgery in FIGO IB2 and IIA2 cervical cancer

700

IB2, IIA2

Arm I: NACT + Radical hysterectomy

Arm II: Radical hysterectomy

DFS

[2 years]

December 2022

NCT01101451

Radiation therapy with or without chemotherapy

in patients with stage I-IIA cervical cancer who

previously underwent surgery

360

I-IIA

Arm I: EBRT/IMRT

Arm II: Cisplatin + EBRT/IMRT

RFS

[11 years]

December 2021

NCT04723875

Postoperative adjuvant chemotherapy in

early-stage cervical cancer that not meet criteria

of adjuvant therapeutic according to NCCN

guideline

306

IB1, IB2, IIA1

Arm I: Chemotherapy

Arm II: No intervention

DFS

[3 years]

January 2026

NCT05277688

Adjuvant concurrent chemoradiotherapy versus

radiotherapy in early-stage cervical cancer

patients

340

IA2-IIB

Arm I: Cisplatin + IMRT

Arm II: IMRT

RFS

[5 years]

December 2027

NCT00980954

Chemotherapy and pelvic radiation therapy with

or without additional chemotherapy in treating

patients with high-risk early-stage cervical cancer

after radical hysterectomy

238

IA2-IIA

Arm I: CCRT

Arm II: CCRT + Chemotherapy

DFS

[4 years]

August 2026

NCT04989647

Intermediate risk cervical cancer: radical surgery

 ± adjuvant radiotherapy

514

IB1-IIA

Arm I: Surgery only

Arm II: Surgery + Radiation

Therapy

DFS

[3 years]

December 2032

NCT03830866

Study of durvalumab with chemoradiotherapy for

women with locally advanced cervical cancer

770

IB2 with positive nodes

to IVA (FIGO2009)

Arm I: Durvalumab + CCRT

Arm II: Placebo + CCRT

PFS

[4.5 years]

June 2023

NCT04138992

A study on the efficacy and safety of

bevacizumab in untreated patients with locally

advanced cervical cancer

150

I-IIIC

Arm I: Bevacizumab + NACT + CCRT

Arm II: Bevacizumab + CCRT

Arm III: CCRT

DFS

[3 years]

May 2022

NCT02853604

Study of ADXS11-001 in subjects with high risk

locally advanced cervical cancer

450

Locally advanced

Arm I: Placebo

Arm II: ADXS11-001

DFS

[5 years]

October 2024

NCT01566240

Induction chemotherapy plus chemoradiation as

first line treatment for locally advanced cervical

cancer

500

IB1- IVA with positive

lymph nodes

Arm I: CCRT

Arm II: Chemotherapy + CCRT

OS

[5 years]

May 2026

NCT03534713

Induction chemotherapy followed by standard

therapy in cervical cancer with aortic lymph node

spread

310

IB1-IVA with positive

para-aortic lymph nodes

Arm I: NACT + CCRT

Arm II: CCRT

OS

[3 years]

December2024

NCT03468010

A trial comparing adjuvant chemotherapy with

observation after concurrent chemoradiotherapy

of cervical cancer (with pelvic or para-aortic

node involvement)

432

IB1-IVA with positive

lymph nodes

Arm I: CCRT

Arm II: Chemotherapy + CCRT

PFS

[3 years]

March 2025

NCT05173272

Induction chemotherapy followed by concurrent

chemoradiation in advanced cervical cancer

286

IB3-IIIB

Arm I; NACT + CCRT

Arm II: CCRT

PFS

[3 years]

February 2028

NCT04974346

Para-aortic prophylactic irradiation for locally

advanced cervical cancer

450

IB2-IV with positive

pelvic lymph nodes and

negative common iliac

and paraaortic lymph

nodes (FIGO 2009)

Arm I: Para-aortic Prophylactic Irradiation + CCRT

Arm II: CCRT

PFS

[3 years]

August 2030

NCT05235516

A study of AK104/placebo combined with

chemoradiotherapy for the treatment of locally

advanced cervical cancer

636

IIIA-IVA

Arm I: AK104 + CCRT

Arm II: Placebo + CCRT

PFS

[4.5 years]

May 2029

NCT01414608

Cisplatin and radiation therapy with or without

carboplatin and paclitaxel in patients with locally

advanced cervical cancer

900

IB1 with node positive,

IB2, IIA, IIB, IIIB, or

IVA (FIGO 2008)

Arm I: CCRT

Arm II: CCRT + Chemotherapy

OS

[5 years]

July 2022

NCT05189028

Study of neoadjuvant chemotherapy versus

definite concurrent chemoradiotherapy for locally

advanced bulk cervical cancer

290

IB3, IIA2, IIB-IVA

Arm I: NACT

Arm II: CCRT

OS

[2 years]

June 2025

NCT04221945

Study of chemoradiotherapy with or without

pembrolizumab (MK-3475) for the treatment of

locally advanced cervical cancer

980

IB2-IVA with positive

nodes (FIGO 2014)

Arm I: CCRT + Pembrolizumab

Arm II: CCRT + Placebo

PFS

[38 months]

OS

[46 months]

December 2024

NCT03635567

Efficacy and safety study of first-line treatment

with pembrolizumab (MK-3475) plus

chemotherapy versus placebo plus chemotherapy

in women with persistent, recurrent, or metastatic

cervical cancer

600

Persistent, recurrent,

metastatic

Arm I: Pembrolizumab + Chemotherapy ± Bevacizumab

Arm II: Placebo + Chemotherapy ± Bevacizumab

PFS

[2 years]

OS

[2 years]

November 2022

NCT04906993

Camrelizumab combined with famitinib malate

for treatment of recurrent/metastatic cervical

cancer

440

Recurrent,

metastatic

Arm I: Camrelizumab + Famitinib malate + Chemotherapy

Arm II: Chemotherapy

PFS

[2 years]

OS

[2 years]

May 2023

NCT04733820

Clinical efficacy of adjuvant chemotherapy in

patients with locally advanced cervical cancer

who did not meet the NCCN guidelines for

adjuvant treatment after NACT combined with

surgery

340

IB3-IIB

Arm I: Chemotherapy

Arm II: No intervention

DFS

[5 years]

February 2028

NCT05367206

Neoadjuvant chemotherapy followed by

chemoradiation versus chemoradiation for stage

IIIC cervical cancer patients: a randomized phase

III trial

280

IIIC

Arm I: albumin-bound paclitaxel and carboplatin + CCRT

Arm II: CCRT

PFS

[3 years]

March 2027

NCT03556839

Platinum chemotherapy plus paclitaxel with

bevacizumab and atezolizumab in metastatic

carcinoma of the cervix

404

IVB, persistent,

recurrent

Arm I: Chemotherapy + Bevacizumab

Arm II: Atezolizumab + Chemotherapy + Bevacizumab

PFS

[48 months]

OS

[48 months]

December 2023

NCT05179239

A study of SHR-1701 plus platinum-containing

chemotherapy with or without BP102

(bevacizumab) as first-line treatment in cervical

cancer

572

Persistent, recurrent,

metastatic

Arm I: SHR-1701 + Chemotherapy + Bevacizumab

Arm II: SHR-1701 + Chemotherapy ± Bevacizumab

Arm III: Placebo + Chemotherapy ± Bevacizumab

AEs

[21 days]

PFS

[10 months]

OS

[26 months]

May 2025

NCT04982237

A study of AK104 plus platinum-containing

chemotherapy ± bevacizumab as first-line

treatment for persistent, recurrent, or metastatic

cervical cancer

440

Persistent, recurrent,

metastatic

Arm I: AK104 + Chemotherapy ± Bevacizumab

Arm II: Placebo + Chemotherapy ± Bevacizumab

PFS

[2 years]

OS

[2 years]

December 2025

NCT03912415

Efficacy and safety of BCD-100 (anti-PD-1) in

combination with platinum-based chemotherapy

with and without bevacizumab as first-line

treatment of subjects with advanced cervical

cancer

316

Recurrent or IVB

Arm I: BCD-100 + Chemotherapy ± Bevacizumab

Arm II: Placebo + Chemotherapy ± Bevacizumab

OS

[3 years]

December 2024

NCT03257267

Study of cemiplimab in adults with cervical

cancer

608

Persistent, recurrent,

metastatic

Arm I: Cemiplimab

Arm II: Investigator's choice Chemotherapy

OS

[40 months]

July 2023

NCT04300647

A study of tiragolumab plus atezolizumab and

atezolizumab monotherapy in participants with

metastatic and/or recurrent PD-L1-positive

cervical cancer

172

Metastatic, recurrent

Arm I: Tiragolumab + Atezolizumab

Arm II: Atezolizumab

ORR

[3 years]

July 2023

NCT04697628

Tisotumab vedotin vs chemotherapy in recurrent

or metastatic cervical cancer

482

Recurrent,

metastatic

Arm I: Tisotumab vedotin

Arm II: Investigator's choice Chemotherapy

OS

[2 years]

May 2024

NCT04864782

QL1604 plus chemotherapy versus chemotherapy

in subjects with stage IVb, recurrent, or

metastatic cervical cancer

458

Recurrent or IVB

Arm I: QL 1604 + Investigator’s choice Chemotherapy

Arm II: Placebo + Investigator’s choice Chemotherapy

AEs

[90 days]

ORR

[6 months]

PFS

[2 years]

July 2022

  1. DFS Disease free survival, OS Overall survival, LACC Locally advanced cervical cancer, CCRT Concurrent chemoradiation therapy, RFS Recurrence-free survival, Chemotherapy Cisplatin or carboplatin + paclitaxel or docetaxel, EBRT Pelvic external-beam radiation therapy, IMRT Intensity-modulated radiation therapy, NACT Neoadjuvant chem