Who is sponsoring NCT05114421?

NCT05114421 is sponsored by M.D. Anderson Cancer Center.

What drugs are being tested in NCT05114421?

Interventions in NCT05114421: Lenvatinib, Pembrolizumab.

What condition does NCT05114421 study?

NCT05114421 studies High Grade Fallopian Tube Serous Adenocarcinoma, High Grade Ovarian Serous Adenocarcinoma, Peritoneal High Grade Serous Adenocarcinoma, Recurrent High Grade Fallopian Tube Serous Adenocarcinoma, Recurrent High Grade Ovarian Serous Adenocarcinoma, Recurrent Primary Peritoneal High Grade Serous Adenocarcinoma.

Is NCT05114421 still recruiting?

NCT05114421 is currently active, enrolled. Last updated 7 August 2025.

Last reviewed 2025-08-07 · How we verify

NCT05114421

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

Pembrolizumab and Lenvatinib for the Treatment of Serous Ovarian Cancer Patients

Active, enrolled Phase 2 Last updated 7 August 2025

What this trial tests

Phase 2 trial testing Lenvatinib in High Grade Fallopian Tube Serous Adenocarcinoma in 30 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

9 November 2021

Primary endpoint
31 January 2026

31 January 2026

Quick facts

Lead sponsor	M.D. Anderson Cancer Center
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	9 November 2021
Primary completion	31 January 2026
Estimated completion	31 January 2026
Sites	1 location across United States

Drugs / interventions tested

Lenvatinib (LENVATINIB) — full drug profile →
Pembrolizumab (pembrolizumab) — full drug profile →

Conditions studied

High Grade Fallopian Tube Serous Adenocarcinoma — all drugs for High Grade Fallopian Tube Serous Adenocarcinoma →
High Grade Ovarian Serous Adenocarcinoma — all drugs for High Grade Ovarian Serous Adenocarcinoma →
Peritoneal High Grade Serous Adenocarcinoma — all drugs for Peritoneal High Grade Serous Adenocarcinoma →
Recurrent High Grade Fallopian Tube Serous Adenocarcinoma — all drugs for Recurrent High Grade Fallopian Tube Serous Adenocarcinoma →

Sponsor

M.D. Anderson Cancer Center — full company profile →

Who can join

18 and older, female only, with High Grade Fallopian Tube Serous Adenocarcinoma or High Grade Ovarian Serous Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This pilot clinical trial studies the effect of pembrolizumab and lenvatinib in treating patients with high-grade serous ovarian cancers. Immunotherapy with monoclonal antibodies such as pembrolizumab may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Lenvatinib is an enzyme inhibitor that may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab and lenvatinib may help to control the disease and provide an effective therapeutic option for cancer.

Publications & conference data

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

Immunotherapy combination approaches: mechanisms, biomarkers and clinical observations.
Butterfield LH, Najjar YG. · · 2024 · cited 210× · PMID 38057451 · DOI 10.1038/s41577-023-00973-8
Paradigm Shift: A Comprehensive Review of Ovarian Cancer Management in an Era of Advancements.
Tavares V, Marques IS, Melo IG, Assis J, et al · · 2024 · cited 85× · PMID 38339123 · DOI 10.3390/ijms25031845
Antiangiogenic Strategies in Epithelial Ovarian Cancer: Mechanism, Resistance, and Combination Therapy.
Jin C, Yuan M, Bu H, Jin C. · · 2022 · cited 36× · PMID 35466318 · DOI 10.1155/2022/4880355
Kinase Inhibitors in the Treatment of Ovarian Cancer: Current State and Future Promises.
Skorda A, Bay ML, Hautaniemi S, Lahtinen A, et al · · 2022 · cited 24× · PMID 36551745 · DOI 10.3390/cancers14246257
Trial Watch: combination of tyrosine kinase inhibitors (TKIs) and immunotherapy.
Petrazzuolo A, Maiuri MC, Zitvogel L, Kroemer G, et al · · 2022 · cited 23× · PMID 35655707 · DOI 10.1080/2162402x.2022.2077898
Patient-Derived Primary Cancer-Associated Fibroblasts Mediate Resistance to Anti-Angiogenic Drug in Ovarian Cancers.
Sulaiman R, De P, Aske JC, Lin X, et al · · 2023 · cited 18× · PMID 36672620 · DOI 10.3390/biomedicines11010112
Therapeutic Strategies Focused on Cancer-Associated Hypercoagulation for Ovarian Clear Cell Carcinoma.
Tamura R, Yoshihara K, Enomoto T. · · 2022 · cited 13× · PMID 35565252 · DOI 10.3390/cancers14092125
Efficacy and Safety of Low-Dose Lenvatinib and Toripalimab in Patients With Recurrent Platinum-Resistant Ovarian Cancer: Study Protocol of a Multicenter, Open-Label, Single-Arm, Phase II Clinical Trial.
Su H, Shang X, Liu H, Wang Y, et al · · 2025 · cited 1× · PMID 39931671 · DOI 10.2147/ijwh.s502665

Verify or expand the search:

Other trials of Lenvatinib

Trials testing the same drug.

NCT07383441 — Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer · Phase 3 · not yet recruiting
NCT07537946 — Local Consolidation After Sintilimab Plus Lenvatinib for Metastatic Liver Cancer · Phase 3 · not yet recruiting
NCT07475026 — A Study of Neoadjuvant Tislelizumab Plus Lenvatinib in Resectable HCC at High Risk of Recurrence · Phase 3 · not yet recruiting
NCT07518706 — Neoadjuvant Tislelizumab-Lenvatinib vs Surgery Alone in Stage Ia HCC With Narrow Margin · Phase 2 · not yet recruiting
NCT07493668 — Fostrox Plus Lenvatinib vs Lenvatinib in Advanced Hepatocellular Carcinoma After First-line Immunotherapy · Phase 2 · not yet recruiting

Other recruiting trials for High Grade Fallopian Tube Serous Adenocarcinoma

Currently open trials in the same condition.

NCT03943173 — Olaparib in Treating Patients With Newly Diagnosed BRCA-Mutant Ovarian, Primary Peritoneal, or Fallopian Cancer Before S · EARLY_PHASE1 · active not recruiting

Other M.D. Anderson Cancer Center trials

Trials by the same sponsor.

NCT07053020 — A Phase 1b/2 Open-label, Dose-ranging Safety and Efficacy Study of Oral Cladribine in Patients With Acute Myeloid Leukem · Phase 1, PHASE2 · not yet recruiting
NCT07052994 — A Phase Ia/Ib Trial of Revumenib Combined With Cytarabine, Daunorubicin, and Gemtuzumab Ozogamicin (GO) in Frontline and · Phase 1 · not yet recruiting
NCT07137481 — Phase II Study of CD5 CAR Engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting Che · Phase 2 · not yet recruiting
NCT07162480 — Phase II Trial of Puxitatug Samrotecan (AZD8205) in Advanced, Recurrent or Metastatic (R/M) Aggressive Adenoid Cystic Ca · Phase 2 · not yet recruiting
NCT07076498 — Engineered HSV-1 M032 for the Treatment of Children and Adults With Newly Diagnosed Diffuse Midline Glioma After Standar · Phase 1 · 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 NCT05114421 (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 M.D. Anderson Cancer Center
Last refreshed: 7 August 2025

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/NCT05114421.

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