NCT03596281: PEMBOV

Pembrolizumab in Combination with Bevacizumab and Pegylated Liposomal Doxorubicin in Patients with Ovarian Cancer

Completed Phase 1 Last updated 18 October 2024

What this trial tests

Phase 1 trial testing Pembrolizumab in Ovarian Cancer in 47 participants. Completed in 11 April 2023.

Timeline

5 December 2018

Primary endpoint
11 March 2021

11 April 2023

Quick facts

Lead sponsor	Gustave Roussy, Cancer Campus, Grand Paris
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	47
Start date	5 December 2018
Primary completion	11 March 2021
Estimated completion	11 April 2023
Sites	1 location across France

Drugs / interventions tested

• Pembrolizumab (pembrolizumab) — full drug profile →
• Bevacizumab (Bevacizumab-Bvzr) — full drug profile →
• pegylated liposomal doxorubicin (PLD) (pegylated-liposomal-doxorubicin-pld) — full drug profile →

Conditions studied

• Ovarian Cancer — all drugs for Ovarian Cancer →

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris — full company profile →

Who can join

18 and older, female only, with Ovarian Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

French multicenter, open-label, phase 1b, evaluating via the mTPI design the paired treatment of pembrolizumab and PLD (cohort A), pembrolizumab and bevacizumab (cohort B) and finally the combination treatment of the three drugs PLD plus bevacizumab and pembrolizumab (cohort C). Thanks to an expansion cohort C+ the ORR will be evaluated in a total of 19 patients at the RP2 D using an exact binomial one-step Fleming-type design.

Cohort A and B will be opened for inclusions at the same time. Once safety of the dual combinations confirmed in cohorts A and B,cohort C will be opened for inclusions.

Publications & conference data

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

1. 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
2. Immuno-Metabolism and Microenvironment in Cancer: Key Players for Immunotherapy.
   Giannone G, Ghisoni E, Genta S, Scotto G, et al · · 2020 · cited 119× · PMID 32575899 · DOI 10.3390/ijms21124414
3. Ovarian Cancer in the Era of Immune Checkpoint Inhibitors: State of the Art and Future Perspectives.
   Maiorano BA, Maiorano MFP, Lorusso D, Maiello E. · · 2021 · cited 60× · PMID 34503248 · DOI 10.3390/cancers13174438
4. Current Understanding on Why Ovarian Cancer Is Resistant to Immune Checkpoint Inhibitors.
   Pawłowska A, Rekowska A, Kuryło W, Pańczyszyn A, et al · · 2023 · cited 41× · PMID 37446039 · DOI 10.3390/ijms241310859
5. Oxidative Stress Inducers in Cancer Therapy: Preclinical and Clinical Evidence.
   Nizami ZN, Aburawi HE, Semlali A, Muhammad K, et al · · 2023 · cited 40× · PMID 37371889 · DOI 10.3390/antiox12061159
6. Metabolic regulation in the immune response to cancer.
   Wu Q, Yu X, Li J, Sun S, et al · · 2021 · cited 40× · PMID 34145990 · DOI 10.1002/cac2.12182
7. Targeting Autophagy with Natural Products as a Potential Therapeutic Approach for Cancer.
   Al-Bari MAA, Ito Y, Ahmed S, Radwan N, et al · · 2021 · cited 34× · PMID 34575981 · DOI 10.3390/ijms22189807
8. Efficacy evaluation of multi-immunotherapy in ovarian cancer: From bench to bed.
   Hu X, Bian C, Zhao X, Yi T. · · 2022 · cited 19× · PMID 36275669 · DOI 10.3389/fimmu.2022.1034903