Ovarian CancerPhase 2PROMPTNCT03430700
Trial of Pembrolizumab Following Weekly Paclitaxel for Platinum-resistant Ovarian, Fallopian Tube or Peritoneal Cancer
A Phase 2 study testing Pembrolizumab in people with Ovarian Cancer and Fallopian Tube Cancer, run by University College, London at 4 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer
- What is being tested?
- Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- 16 May 2019to 3 Dec 2025
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have a diagnosis of high grade recurrent ovarian/fallopian tube or primary non-mucinous peritoneal cancer
- 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
- Be >=18 years of age on day of signing informed consent
- Patients should be treated with a minimum of 4 cycles of weekly paclitaxel for recurrent disease. [Non-platinum-based therapy given for CT/MR documented recurrence where further platinum therapy considered unsuitable]
- Patients can have had up to 3 prior lines of platinum-based chemotherapy for ovarian cancer before starting weekly paclitaxel
- Patients must have achieved at least stable disease or response following a minimum of four cycles of weekly paclitaxel (measured by CT/MR)
Show all 14Show fewer
- Trial treatment with pembrolizumab must start within 8 weeks after last paclitaxel dose
- Availability of archival tissue
- Fresh tumour biopsy should be taken at baseline if this is judged by radiological assessment to be technically feasible. If a biopsy is taken at baseline, then a second biopsy should be taken, if feasible before the start of cycle 4
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Willing and able to comply with the protocol for the duration of the study, including the treatment plan, investigations required and follow up visits
- Demonstrate adequate organ function as defined in the protocol, all screening labs should be performed within 10 days of treatment initiation.
- Patients of childbearing potential should have a negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
- Patients of childbearing potential must be willing to use an adequate method of contraception as outlined in protocol from the start of treatment through to 4 months after the last dose of study medication
Who cannot join
- Prior therapy with an anti-PD-1, anti-PD-L1 or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137)
- Has a diagnosis of low grade or mucinous ovarian cancer
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (dose exceeding 10 mg daily of prednisone equivalent) 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). Use of inhaled steroids is permitted.
- Has a known history of active TB (Bacillus Tuberculosis)
- Has known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known Hepatitis C virus (defined as HCV RNA [qualitative] is detected)*
- Has a known history of Human Immunodeficiency Virus (HIV)
Show all 21Show fewer
- Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks (could consider shorter interval for kinase inhibitors or other short half-life drugs) prior to registration.
- Note: Participants must have recovered from all AEs due to previous therapies to ≤Grade 1 or baseline. Participants with ≤Grade 2 neuropathy may be eligible
- Has received prior radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (a maximum of 2 weeks radiotherapy is allowed) to non-CNS disease
- 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
- Active central nervous system (CNS) metastases and/or carcinomatous meningitis; patients with previously treated brain metastases may participate
- 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 hormone therapy (e.g. levothyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is permitted
- Has a corrected serum calcium of >1.5 x ULN despite maximal antihypercalcaemic therapy
- Has a history of (non-infectious) pneumonitis/ interstitial lung disease that required steroids or has current pneumonitis or has a history of interstitial lung disease
- 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
- Has an active infection requiring systemic therapy
- Has symptoms of bowel obstruction in the past three months
- 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
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
- Is pregnant or breastfeeding, or expecting to conceive children within the projected duration of the trial, starting with the screening visit through to 4 months after the last dose of trial treatment
- Has received a live vaccine within 30 days of planned start of study treatment. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
Barts
London
Imperial
London
UCLH
London
Churchill Hospital
Oxford
About this study
Official title: Phase II Trial of Maintenance Pembrolizumab Following Weekly Paclitaxel for Platinum-resistant Ovarian, Fallopian Tube or Peritoneal Cancer
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.
Read the detailed description
This study aimed to investigate the effect of maintenance pembrolizumab in patients who underwent treatment with weekly paclitaxel for platinum-resistant recurrent ovarian cancer and either responded or progressed after a minimum of 4 cycles of treatment.
Participants were enrolled to receive 3 weekly pembrolizumab until progression. This was a non-randomised phase II study, and the population may be different from those who received paclitaxel and bevacizumab.
- Conditions
- Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer
- Being tested
- Pembrolizumab
- Keywords
- platinum-resistant
- Medical subject headings
- Ovarian Neoplasms, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabDrug
Also called Keytruda
Intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Maintenance treatment with trial drug pembrolizumab; 200mg IV every 21 days until progression, unacceptable toxicity, patient or clinician decision. Receives: Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival Rate at 6 Months From Start of Study Treatment (Maintenance Pembrolizumab)
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), with at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions or unequivocal progression of existing non-target lesions is also considered progression.
Using A'Hern's single-stage phase II design with a one-sided 5% significance level and 80% power, ≥16 participants needed to be alive and progression-free at 6 months for the protocol aim to be reached.
Measured: 6 months from start of study treatment (maintenance pembrolizumab)
Secondary outcomes (4)
Progression Free Survival at 6 Months Measured From the Start of Pre-trial Weekly Paclitaxel
Progression Free Survival at 6 months was measured from the start of pre-trial weekly paclitaxel using Kaplan-Meier estimates with censoring on the date of last study assessment.
Measured: 6 months from the start of weekly previously administered standard of care paclitaxel to the date of first progression or death from any cause.
Overall Survival
Kaplan-Meier estimates were used to analyse overall survival from the start of maintenance pembrolizumab to the date of death from any cause.
Measured: From start of study treatment until the date of death from any cause or end of study whichever came first, assessed up to 50 months.
Disease Response
Disease response as per Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1, using CT scan assessment: Complete Response- disappearance of all target lesions; Partial Response at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; Progressive Disease - at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (Note: the appearance of one or more new lesions and unequivocal progression is also considered progression); Stable Disease - neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study.
Measured: Before cycle 1, cycle 4 and cycle 7 of study treatment, then every 12 weekly (4 cycles) during treatment until progression up to 24 months.
Treatment Compliance
The number and percentage of patients who stopped treatment due to any reason other than disease progression were analysed. A median of 3.5 cycles of pembrolizumab were given. Nineteen participants stopped due to disease progression and one participant discontinued due to a treatment related adverse event.
Measured: Date of first study treatment administration dose until the date of last administration dose of study treatment, assessed for duration of study treatment in all participants: up to 42 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2018
- Study start16 May 2019
- Primary completion3 Dec 2025
- Study completion3 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Maintenance treatment with trial drug pembrolizumab; 200mg IV every 21 days until progression, unacceptable toxicity, patient or clinician decision.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- UCL Cancer Trials Centre, Study chair, UCL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03430700
- Sponsor's protocol ID
- UCL/17/0629
- Acronym
- PROMPT
- Status last verified
- May 2026
- First submitted
- 6 Feb 2018
- Last updated
- 20 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No