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Trial of Pembrolizumab Following Weekly Paclitaxel for Platinum-resistant Ovarian, Fallopian Tube or Peritoneal Cancer (PROMPT)

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ClinicalTrials.gov Identifier: NCT03430700
Recruitment Status : Not yet recruiting
First Posted : February 13, 2018
Last Update Posted : October 11, 2018
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
University College, London

Brief Summary:
The overall aim of the study is to demonstrate a clinically meaningful extension of progression free survival using maintenance pembrolizumab. The aim of the translational research is to study the immune microenvironment before and during pembrolizumab therapy.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Fallopian Tube Cancer Peritoneal Cancer Drug: Pembrolizumab Phase 2

Detailed Description:

This study aims to investigate the effect of maintenance pembrolizumab in patients who have undergone treatment with weekly paclitaxel for platinum-resistant recurrent ovarian cancer and have either responded or have not progressed after a minimum of 4 cycles of treatment.

In this study patients will receive 3 weekly pembrolizumab until progression and the investigators will monitor the immune microenvironment by tumour biopsy and blood sampling before starting pembrolizumab and again before cycle 4 of treatment. The clinical endpoint will be to demonstrate a worthwhile improvement in the 6 month median PFS and to study possible predictive markers or response to pembrolizumab. This is a non-randomised phase II study, and the population may be different from those who received paclitaxel and bevacizumab.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Intervention Model: Single Group Assignment
Intervention Model Description: All patients will receive treatment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Maintenance Pembrolizumab Following Weekly Paclitaxel for Platinum-resistant Ovarian, Fallopian Tube or Peritoneal Cancer
Estimated Study Start Date : February 1, 2019
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : January 1, 2022


Arm Intervention/treatment
Experimental: Treatment
All patient will receive Pembrolizumab (100 mg/ 4mL) every 3 weeks for a maximum of 2 years. Pembrolizumab 200mg will be administered as a 30 minute IV infusion every 3 weeks.
Drug: Pembrolizumab
Intravenous infusion
Other Name: Keytruda




Primary Outcome Measures :
  1. Progression-Free Survival (PFS) measured from start of study treatment to the date of objective progression (investigator assessed using RECIST 1.1) or date of death from any cause (in the absence of progression). [ Time Frame: 6 months ]
    Progression free survival (PFS) measure from the first date of trial treatment to 6 months of treatment.


Secondary Outcome Measures :
  1. Overall survival measured from start of study treatment to the date of death from any cause [ Time Frame: 4 years ]
    Overall survival (death from any cause) measured from the start of study treatment

  2. Disease response [ Time Frame: 4 years ]
    Disease response investigator assessed by RECIST 1.1, from when a patient starts trial treatment until patients starts new anti-cancer treatment



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients must have a diagnosis of recurrent ovarian/fallopian tube or primary non-mucinous peritoneal cancer
  2. Be willing and able to provide written informed consent for the trial, indicating that the patient has been informed of and understands the experimental nature of the study, possible risks and benefits, trial procedures, and alternative options
  3. Be at least 18 years of age on day of signing informed consent
  4. Patients should be treated with at least 4 cycles of weekly paclitaxel for first platinum resistant relapse (platinum free interval PFI ≤ 6 months). PFI defined as the time elapsed between the last dose of platinum and the documented evidence of disease progression per RECIST 1.1)
  5. Patients must have at least stable disease or response to paclitaxel (measured by CT/MR). Patients can have had 1 line of previous platinum treatment for platinum-sensitive disease
  6. Trial treatment must start within 8 weeks after last paclitaxel dose
  7. Availability of archival tissue
  8. Patient has disease amenable to biopsy after paclitaxel and is willing to have a biopsy at baseline and before start of cycle 4 after starting trial treatment
  9. CT chest, abdominal and pelvic scan within 28 days of registration
  10. ECOG performance status of 0 or 1
  11. Willing and able to comply with the protocol for the duration of the study, including the treatment plan, investigations required and follow up visits
  12. Demonstrate adequate organ function (all screening labs should be performed within 10 days of treatment initiation.)
  13. Female subject of childbearing potential should have a negative urine or serum pregnancy. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
  14. Female subjects of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 19 weeks after the last dose of study medication

Exclusion Criteria:

  1. Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment
  2. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment (n.b. the use of physiologic doses of corticosteroids may be approved after consultation with UCL CTC), excepting use of inhaled steroids
  3. Has a known history of active TB (Bacillus Tuberculosis)
  4. Has known history of active Hepatitis B (defined as Hepatitis B surface antigene.g., [HBsAg] reactive) or known Hepatitis C virus (e.g., (defined as HCV RNA [qualitative] is detected)*
  5. Immunocompromised patients (e.g. known HIV positive status)*
  6. Hypersensitivity to pembrolizumab or any of its excipients
  7. Anti-cancer monoclonal antibody therapy within 4 weeks prior to registration
  8. Has had prior chemotherapy within 2 weeks, or has had targeted small molecule therapy, or radiation therapy within 2 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent
  9. Either Patients with concurrent or previous malignancy within the last 5 years (except Stage I grade 1 endometrial cancer; in situ cervical cancer; DCIS of the breast) that could compromise assessment of the primary or secondary endpoints of the trial
  10. Active central nervous system (CNS) metastases and/or carcinomatous meningitis; subjects with previously treated brain metastases may participate provided they are

    1. Stable, without evidence of disease progression by imaging at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline
    2. Have no evidence of new or enlarged metastases
    3. Are not using steroids for at least 7 days prior to trial treatment
  11. Has active autoimmune disease that required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids (at doses >10mg prednisolone daily or equivalent) or immunosuppressive drugs) except vitiligo or resolved childhood asthma/atopy. Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is permitted
  12. Has a corrected serum calcium of >1.5 x ULN despite maximal antihypercalcaemic therapy
  13. Has known history of, or any evidence of active, non-infectious pneumonitis or has a history of interstitial lung disease
  14. Has a newly diagnosed venous thrombotic event (e.g. PE, DVT) untreated with anticoagulation. Patients must have received at least 14 days of anticoagulation for a new thrombotic event and be suitable for continued therapeutic anticoagulation during trial participation. Patients are excluded if they have a history of arterial thrombosis
  15. Has an active infection requiring systemic therapy
  16. Either Any serious and/or unstable pre-existing medical, psychiatric or other condition that, in the treating clinician's judgement could interfere with patient safety or obtaining informed consent
  17. Has known psychiatric or substance abuse disorders that would interfere with co-operation with the requirements of the trial
  18. Is pregnant or breastfeeding, or expecting to conceive children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment
  19. Prior therapy with an anti-PD-1, anti-PD-L1 or anti-PD-L2 agent
  20. Has received a live vaccine within 30 days of planned start of study therapy. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed
  21. Peripheral neuropathy ≥ grade 3 (CTCAE v4.03) (severe symptoms; limiting self care ADL)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03430700


Contacts
Contact: PROMPT Trial Coordinator +44 (0)2076799872 ctc.prompt@ucl.ac.uk

Sponsors and Collaborators
University College, London
Merck Sharp & Dohme Corp.
Investigators
Study Chair: UCL Cancer Trials Centre UCL

Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT03430700     History of Changes
Other Study ID Numbers: UCL/17/0629
First Posted: February 13, 2018    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University College, London:
platinum-resistant

Additional relevant MeSH terms:
Fallopian Tube Neoplasms
Peritoneal Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Fallopian Tube Diseases
Adnexal Diseases
Genital Diseases, Female
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Paclitaxel
Pembrolizumab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action