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NCT03312114

Anti-PD-L1 and SAbR for Ovarian Cancer

Terminated Phase 2 Results posted Last updated 12 November 2020
What this trial tests

Phase 2 trial testing Avelumab in Recurrent Epithelial Cancer of Ovary in 5 participants. Terminated before completion.

Timeline
9 November 2017
Primary endpoint
19 March 2019
19 March 2019

Quick facts

Lead sponsorUniversity of Texas Southwestern Medical Center
PhasePhase 2
StatusTerminated
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment5
Start date9 November 2017
Primary completion19 March 2019
Estimated completion19 March 2019
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Texas Southwestern Medical Center

Who can join

18 and older, female only, with Recurrent Epithelial Cancer of Ovary or Primary Peritoneal Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

To Assess Overall Clinical Response Rates Per RECIST Criteria. Primary · 1 year,4 months

Analysis of (with safety lead-in) trial of combined Avelumab (MSB0010718C) anti-PD-L1checkpoint blockade with SAbR for Recurrent Ovarian and peritoneal ,fallopian tube cancer (ROPT) is to assess overall clinical response rates per RECIST criteria .

GroupValue95% CI
Recurrent Ovarian and Peritoneal ,Fallopian Tube Cancer (ROP0
Overall Survival Secondary · 1 year, 4 months

Patients were started on alternative therapy and were not followed after starting alternative therapy. Study was stopped because drug was found to be ineffective by the pharmaceutical company

GroupValue95% CI
Single ArmNA

Adverse events — posted to ClinicalTrials.gov

Time frame: The adverse event were 6 months from enrollment. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Concurrent Anti-PD-L1 + SAbR to Metastasis
Serious: 0/5 (0%)
Deaths: 3/5
Other adverse events (5 terms — click to expand)

ReactionSystemConcurrent Anti-PD-L1 + SA…
LYMPHOCYTE COUNT DECREASEDBlood and lymphatic system disorders
FATIGUEGeneral disorders
CONSTIPATIONGastrointestinal disorders
ANOERXIAGeneral disorders
VOMITINGGeneral disorders

Data from ClinicalTrials.gov NCT03312114 adverse events section.

Sponsor's own description

Programmed death-1 receptor ligand (PD-L1) the ligand for PD-1 is a key therapeutic target in the reactivation of the immune response against multiple cancers. Pharmacologic inhibitors of PD-1 have also demonstrated significant anti-tumor activity and are currently under active clinical exploration. avelumab (MSB0010718C; anti-PD-L1 is a fully human anti-PD-L1 igG1 antibody that has shown promising efficacy and an acceptable safety profile in multiple tumor types. Radiation therapy (RT) is one of the mainstream treatments of cancer therapy along with surgery and chemotherapy, yet RT is the only treatment that does not leave the patients immunocompromised (unlike chemotherapy) and keeps the dying tumor / antigen depot within the host (unlike surgery), providing an opportunity for antigen presentation. Therefore, RT is a rational choice to combine with immunotherapy for cancer treatment.

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. Product review: avelumab, an anti-PD-L1 antibody.
    Collins JM, Gulley JL. · · 2019 · cited 62× · PMID 30481100 · DOI 10.1080/21645515.2018.1551671
  3. The Controversial Role of PD-1 and Its Ligands in Gynecological Malignancies.
    Marinelli O, Annibali D, Aguzzi C, Tuyaerts S, et al · · 2019 · cited 33× · PMID 31681606 · DOI 10.3389/fonc.2019.01073
  4. Radiotherapy as a New Player in Immuno-Oncology.
    Wang SJ, Haffty B. · · 2018 · cited 19× · PMID 30558196 · DOI 10.3390/cancers10120515
  5. Targeted therapy and immunotherapy: Diamonds in the rough in the treatment of epithelial ovarian cancer.
    Huang X, Li XY, Shan WL, Chen Y, et al · · 2023 · cited 14× · PMID 37033645 · DOI 10.3389/fphar.2023.1131342
  6. The Perfect Combination: Enhancing Patient Response to PD-1-Based Therapies in Epithelial Ovarian Cancer.
    James NE, Woodman M, DiSilvestro PA, Ribeiro JR. · · 2020 · cited 14× · PMID 32756436 · DOI 10.3390/cancers12082150
  7. Radiobiology of stereotactic ablative radiotherapy (SABR): perspectives of clinical oncologists.
    Li S, Shen L. · · 2020 · cited 11× · PMID 32742453 · DOI 10.7150/jca.44408
  8. Defining the role of high-dose radiation in oligometastatic & oligorecurrent cervical cancer.
    Mangaj A, Chopra S, Nout RA. · · 2021 · cited 7× · PMID 35295014 · DOI 10.4103/ijmr.ijmr_298_21

Verify or expand the search:

Other trials of Avelumab

Trials testing the same drug.

Other recruiting trials for Recurrent Epithelial Cancer of Ovary

Currently open trials in the same condition.

Other University of Texas Southwestern Medical Center trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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/NCT03312114.

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