Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT04919629 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

APL-2 and Pembrolizumab Versus APL-2, Pembrolizumab and Bevacizumab Versus Bevacizumab Alone for the Treatment of Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer and Malignant Effusion

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary completion date: Apr 30, 2026 to Apr 30, 2028
    • Study completion date: Apr 30, 2027 to Apr 30, 2028
    • Study description expanded, about 1 word
    v27
  2. Minor Re-verified, no change to tracked fieldsv26
  3. Notable Start date: Feb 17, 2023 to Apr 27, 2023
    • Primary completion date: Dec 1, 2025 to Apr 30, 2026
    • Study completion date: Dec 1, 2025 to Apr 30, 2027
    v25
  4. Notable Enrollment target: 40 to 60v24 Show 8 more changesShow less
    • Primary endpoints: 1 to 2
    • Primary completion date: Apr 30, 2026 to Dec 1, 2025
    • Study completion date: Apr 30, 2027 to Dec 1, 2025
    • Start date: Apr 27, 2023 to Feb 17, 2023
    • Interventions: Bevacizumab (Biological), Pegcetacoplan (Biological), Pembrolizumab (Biological), Quality-of-Life Assessment (Other), Questionnaire… to Bevacizumab (Biological), Biopsy (Procedure), Biospecimen Collection (Procedure), Pegcetacoplan (Drug), Pembrolizumab (Biological)…
    • Eligibility criteria expanded, about 211 words
    • Study description expanded, about 445 words
    • Study arms: 3 to 5
  5. Minor Eligibility criteria shortened, about 1 wordv23
Show 21 earlier versionsHide 21 earlier versions
  1. Minor Collaborators expanded, about 4 wordsv22
  2. Minor Primary completion date: Dec 15, 2025 to Apr 30, 2026
    • Study completion date: Dec 15, 2025 to Apr 30, 2027
    v21
  3. Minor Start date changed from estimate of Apr 15, 2023 to Apr 27, 2023v20
  4. Minor Eligibility criteria revisedv19
  5. Notable Start date: Feb 28, 2023 to Apr 15, 2023
    • Eligibility criteria expanded, about 239 words
    v18
  6. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date: Mar 2023 to Feb 28, 2023
    • Site details revised
    v17
  7. Minor Start date: Jan 2023 to Mar 2023v16
  8. Minor Start date: Dec 15, 2022 to Jan 2023v15
  9. Notable Start date: Oct 15, 2022 to Dec 15, 2022
    • Primary and study completion dates: Oct 15, 2025 to Dec 15, 2025
    v14
  10. Notable Start date: Aug 15, 2022 to Oct 15, 2022
    • Primary and study completion dates: Aug 15, 2025 to Oct 15, 2025
    v13
  11. Notable Start date: Jul 15, 2022 to Aug 15, 2022
    • Primary and study completion dates: Jul 15, 2025 to Aug 15, 2025
    v12
  12. Notable Start date: May 15, 2022 to Jul 15, 2022
    • Primary and study completion dates: May 15, 2025 to Jul 15, 2025
    v11
  13. Notable Start date: Apr 15, 2022 to May 15, 2022
    • Primary and study completion dates: Apr 15, 2025 to May 15, 2025
    v10
  14. Notable Start date: Mar 1, 2022 to Apr 15, 2022
    • Primary and study completion dates: Mar 1, 2025 to Apr 15, 2025
    v9
  15. Minor Primary and study completion dates: Feb 1, 2025 to Mar 1, 2025
    • Start date: Feb 1, 2022 to Mar 1, 2022
    v8
  16. Notable Start date: Dec 1, 2021 to Feb 1, 2022
    • Primary completion date: Dec 1, 2024 to Feb 1, 2025
    • Study completion date: Dec 1, 2025 to Feb 1, 2025
    v7
  17. Notable Start date: Oct 1, 2021 to Dec 1, 2021
    • Primary completion date: Oct 1, 2024 to Dec 1, 2024
    • Study completion date: Oct 1, 2025 to Dec 1, 2025
    v6
  18. Notable Start date: Sep 1, 2021 to Oct 1, 2021
    • Primary completion date: Sep 1, 2024 to Oct 1, 2024
    • Study completion date: Sep 1, 2025 to Oct 1, 2025
    v5
  19. Minor Re-verified, no change to tracked fieldsv4
  20. Notable Start date: Jul 1, 2021 to Sep 1, 2021v3 Show 4 more changesShow less
    • Primary completion date: Jul 1, 2024 to Sep 1, 2024
    • Study completion date: Jul 1, 2025 to Sep 1, 2025
    • Interventions: Bevacizumab (Biological), Pegcetacoplan (Drug), Pembrolizumab (Biological), Quality-of-Life Assessment (Other), Questionnaire… to Bevacizumab (Biological), Pegcetacoplan (Biological), Pembrolizumab (Biological), Quality-of-Life Assessment (Other), Questionnaire…
    • Study description shortened, about 183 words
  21. Minor Enrollment target: 50 to 40
    • Study description expanded, about 6 words
    • Eligibility criteria expanded, about 2 words
    v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This phase II trial studies the effect of APL-2 when given in combination with either pembrolizumab or pembrolizumab and bevacizumab compared with bevacizumab alone in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that has come back (recurrent) and a buildup of fluid and cancer cells (malignant effusion). APL-2 may limit tumor progression, decrease malignant effusion production, and improve the immune system's response against cancer cells. 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. Bevacizumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Giving APL-2 together with either pembrolizumab or pembrolizumab and bevacizumab may work better in treating patients with ovarian, fallopian tube, or primary peritoneal cancer and malignant effusion compared to bevacizumab alone.
Trial Details
NCT Number NCT04919629
Lead Sponsor Roswell Park Cancer Institute
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)
Fallopian Tube Carcinosarcoma, Fallopian Tube Clear Cell Adenocarcinoma, Fallopian Tube Endometrioid Adenocarcinoma, Fallopian Tube Serous Adenocarcinoma, Ovarian Carcinosarcoma, Ovarian Clear Cell Adenocarcinoma, Ovarian Endometrioid Adenocarcinoma, Ovarian Serous Adenocarcinoma +7 more
Related terms Fallopian Tube Neoplasms, Ovarian Neoplasms
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov