NCT02914470: PROLOG

A Phase 1b to Assess the Safety and Tolerability of Carboplatin-cyclophosphamide Combined With Atezolizumab, an Antibody That Targets Programmed Death Ligand 1 (PD-L1), in Patients With Advanced Breast Cancer and Gynaecologic Cancer

Completed Phase 1 Last updated 18 October 2021

What this trial tests

Phase 1 trial testing carbplatin, cyclophophamide, atezolizumab in Breast Cancer in 12 participants. Completed in 1 October 2021.

Timeline

1 January 2017

Primary endpoint
1 August 2017

1 October 2021

Quick facts

Lead sponsor	The Netherlands Cancer Institute
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	12
Start date	1 January 2017
Primary completion	1 August 2017
Estimated completion	1 October 2021
Sites	1 location across Netherlands

Drugs / interventions tested

• carbplatin, cyclophophamide, atezolizumab — full drug profile →

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →
• Cervix Cancer — all drugs for Cervix Cancer →
• Ovarian Cancer — all drugs for Ovarian Cancer →
• Endometrial Cancer — all drugs for Endometrial Cancer →

Sponsor

The Netherlands Cancer Institute

Who can join

18 and older, any sex, with Breast Cancer or Cervix Cancer. 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.

• Toxicity; Incidence of toxicity, graded according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 4.03
  Time frame: up to 30 days after end of treatment
  Adverse events will be graded according to NCI Common Toxicity Criteria version 4.03

Sponsor's own description

This is a single centre, 3+3, dose finding, open label, phase 1b clinical study of carboplatin and cyclophosphamide, in combination with atezolizumab.

Publications & conference data

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

1. Improvement of the anticancer efficacy of PD-1/PD-L1 blockade via combination therapy and PD-L1 regulation.
   Wu M, Huang Q, Xie Y, Wu X, et al · · 2022 · cited 336× · PMID 35279217 · DOI 10.1186/s13045-022-01242-2
2. Cervical Cancer Immunotherapy: Facts and Hopes.
   Ferrall L, Lin KY, Roden RBS, Hung CF, et al · · 2021 · cited 255× · PMID 33888488 · DOI 10.1158/1078-0432.ccr-20-2833
3. Tumor Microenvironment in Ovarian Cancer: Function and Therapeutic Strategy.
   Yang Y, Yang Y, Yang J, Zhao X, et al · · 2020 · cited 168× · PMID 32850861 · DOI 10.3389/fcell.2020.00758
4. PD-1/PD-L1 Inhibitors in Cervical Cancer.
   Liu Y, Wu L, Tong R, Yang F, et al · · 2019 · cited 113× · PMID 30774597 · DOI 10.3389/fphar.2019.00065
5. Immunotherapy in endometrial cancer: new scenarios on the horizon.
   Di Tucci C, Capone C, Galati G, Iacobelli V, et al · · 2019 · cited 83× · PMID 30887763 · DOI 10.3802/jgo.2019.30.e46
6. Immunotherapy in endometrial cancer: rationale, practice and perspectives.
   Cao W, Ma X, Fischer JV, Sun C, et al · · 2021 · cited 79× · PMID 34134781 · DOI 10.1186/s40364-021-00301-z
7. Checkpoint inhibitors in endometrial cancer: preclinical rationale and clinical activity.
   Mittica G, Ghisoni E, Giannone G, Aglietta M, et al · · 2017 · cited 78× · PMID 29163851 · DOI 10.18632/oncotarget.20042
8. Immunotherapy for HER2-positive breast cancer: recent advances and combination therapeutic approaches.
   Ayoub NM, Al-Shami KM, Yaghan RJ. · · 2019 · cited 69× · PMID 30697064 · DOI 10.2147/bctt.s175360