Study of Pembrolizumab Combination With Chemotherapy in Platinum-sensitive Recurrent Low-grade Serous Ovarian Cancer (PERCEPTION)

  • STATUS
    Recruiting
  • End date
    Nov 1, 2025
  • participants needed
    33
  • sponsor
    North Eastern German Society of Gynaecological Oncology
Updated on 14 July 2022
doxorubicin
carboplatin
gemcitabine
pembrolizumab
bevacizumab
cancer chemotherapy
adenocarcinoma
ovarian cancer
fallopian tube
platinum-based chemotherapy
peritoneal cancer
cancer of the ovary

Summary

This is a phase II, single arm, multi-centre study to assess the efficacy of pembrolizumab in combination with platinum-based chemotherapy (investigator's choice: carboplatin + gemcitabine or carboplatin + pegylated liposomal doxorubicin) administered concurrent to chemotherapy and in maintenance, in patients with low grade ovarian cancer (including patients with primary peritoneal and / or fallopian tube adenocarcinoma) having platinum-sensitive relapse (platinum-free interval > 6 months).

Description

In this study, we will evaluate efficacy and safety of pembrolizumab in combination with chemotherapy (physician's choice) in subjects with low-grade ovarian cancer.

Patients will receive Pembrolizumab 200mg q3w until progression or unacceptable toxicity, for a maximum of 35 cycles PLUS one of the following standard chemotherapies for LGSOC (investigators' choice):

Carboplatin AUC 4 + Gemcitabine 1000mg/m² (q3w for 3-6 cycles) or Carboplatin AUC 5 + pegylated liposomal Doxorubicin 30mg/m² (q4w for 3-6 cycles). As primary objective 12-month progression free survival (PFS) rate will be analysed.

About 2 sites in Germany will participate in this study to recruit 33 patients in 24 months.

Details
Condition Ovarian Cancer, Low Grade Serous Carcinoma, Primary Peritoneal Carcinoma, Fallopian Tube Cancer
Treatment Pembrolizumab
Clinical Study IdentifierNCT04575961
SponsorNorth Eastern German Society of Gynaecological Oncology
Last Modified on14 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Female, age at least 18 years
Histologically diagnosed low-grade serous ovarian cancer, fallopian tube cancer, or primary peritoneal cancer
Patients must have completed at least 1 previous course of platinum-containing therapy (e.g., combination with carboplatin or cisplatin. Maintenance therapy with bevacizumab and/or endocrine agents is allowed)
Progression or recurrence after platinum-containing therapy, occurring no sooner than 6 months after completion of the last dose of platinum chemotherapy (platinum sensitive disease)
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Women of childbearing potential should not become pregnant while on the Product and should not be pregnant at the beginning of treatment. A pregnancy test should be performed on all women of childbearing potential prior to receiving the Product. Women of childbearing potential must agree to follow contraceptive guidance during the treatment period and for 6 months after receiving the last dose of the study therapy
The participant (or legally acceptable representative if applicable) provides written informed consent for the trial
Availability of archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue

Exclusion Criteria

High-grade ovarian cancer
Persistent ≥Grade 2 hematologic toxicity from prior cancer therapy 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
Note: If participant received major surgery, they must have recovered adequately from the
toxicity and/or complications from the intervention prior to starting study treatment
Has received 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 (e.g
CTLA-4, OX 40, CD137)
Is eligible for carboplatin-based doublet therapy in combination with bevacizumab in
the relapse situation, since no treatment with bevacizumab has been administered in
the first line therapy
Has received prior systemic anti-cancer therapy including investigational agents
within 4 weeks
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 (≤2 weeks of radiotherapy) to non-CNS disease
Has received a live vaccine within 30 days prior to the first dose of study drug
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 (e.g., FluMist®) are live attenuated vaccines and are not allowed
Is currently participating in or has participated in a study of an investigational
agent or has used an investigational device within 4 weeks prior to the first dose of
study treatment
Note: Participants who have entered the follow-up phase of an investigational study may
participate as long as it has been 4 weeks after the last dose of the previous
investigational agent
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
(in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of
immunosuppressive therapy within 7 days prior to the first dose of study drug
Has a known additional malignancy that is progressing or has required active treatment
within the past 3 years. Note: Participants with basal cell carcinoma of the skin
squamous cell carcinoma of the skin, or carcinoma in situ (e.g. breast carcinoma
cervical cancer in situ) that have undergone potentially curative therapy are not
excluded
Has known active CNS metastases and/or carcinomatous meningitis. Participants with
previously treated brain metastases may participate provided they are radiologically
stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging
(note that the repeat imaging should be performed during study screening), clinically
stable and without requirement of steroid treatment for at least 14 days prior to
first dose of study treatment
Has a bleeding tumor
Has hypersensitivity to any of the study drugs the patient will be treated with and/or
to any of the excipients of the study drugs the patient will be treated with
Has active autoimmune disease that has required systemic treatment in the past 2 years
(i.e. with use of disease modifying agents, corticosteroids or immunosuppressive
drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid
replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a
form of systemic treatment
Has a history of (non-infectious) pneumonitis that required steroids or has current
pneumonitis
Has an active infection requiring systemic therapy
Has a known history of Human Immunodeficiency Virus (HIV)
Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg]
reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] has been
detected) infection
Has a known history of active TB (Bacillus Tuberculosis)
Has a history or current evidence of any condition, therapy, or laboratory abnormality
that might confound the results of the study, interfere with the subject's
participation for the full duration of the study, or is not in the best interest of
the subject to participate, in the opinion of the treating investigator
Has had an allogenic tissue/ solid organ transplant
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 within the projected duration
of the study, starting with the screening visit through 6 months after the last dose
of trial treatment
Patients unable to be regularly followed for any reason (geographic, familiar, social
psychologic, housed in an institution e.g. prison because of a court agreement or
administrative order)
Subjects that are depending on the sponsor/CRO or investigational site as well as on
the investigator
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