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NCT Number: NCT03989336

A Study of the Pan-immunotherapy in Patients With Relapsed/Refractory Ovarian Cancer

Ovarian cancer is the most lethal gynecological cancer and the 5th leading cause of cancer death in women. Platinum chemotherapy has been widely adopted as a standard treatment for advanced ovarian cancer, the response rates in patients with relapsed/refractory ovarian cancer is unacceptably low. PD-1 blockade has been developed to a new class of cancer immunotherapy that could restore an adequate immunosurveillance against the neoplasm and enhance T-cell-mediated anticancer immune responses. Manganese has been confirmed to activate antigen-presenting cells and function as mucosal immunoadjuvants in pre-clinical studies. This two-arm, phase I/II study is designed to assess the safety and efficacy of combined therapy of anti-PD-1 antibody and chemotherapy with or without Manganese priming.

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Key information

Conditions

Ovarian Cancer Adnexal Diseases Disease Attributes Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Urogenital Diseases Urogenital Neoplasms

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Biotherapeutic Department of Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects must have histologically proven relapsed or refractory ovarian cancer (Refractory was defined as a lack of response to or progression during the frontline treatment; relapsed was defined as progression after the frontline treatment), including patients diagnosed with primary carcinoma of fallopian tube or peritoneum carcinoma.
  • Female.
  • ≥ 18 years old.
  • Life expectancy of at least 6 months.
  • Eastern Cooperative Oncology Group performance status 0-2.
  • Radiographic imaging (CT/MRI/PET-CT) indicated recurrence or metastasis; or cancer cells in ascites are positive; or CA125 concentration in the peripheral blood is more than 2 times the upper limit of normal value.
  • Subjects must have received at least two frontline therapies, at least one of which is platinum-containing.
  • Subjects with Anti-PD-1 antibody treatment history are eligible which must be resistance.
  • Adequate organ function.
  • Female participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study drug.

Exclusion criteria

  • Subjects with any autoimmune disease or history of syndrome that requires corticosteroids or immunosuppressive medications.
  • Serious uncontrolled medical disorders or active infections, pulmonary infection especially.
  • Prior organ allograft.
  • Women who are pregnant or breastfeeding.
  • Women with a positive pregnancy test on enrollment or prior to investigational product administration.
  • Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.
  • Subjects with previous or concurrent other malignancies.

Treatment and study plan

Manganese Chloride

Drug

Administered by inhalation at 0.4mg/kg twice per week in the first 3-week cycle, and then inhaled 0.4mg/kg twice in the first week of each 3-week cycle thereafter

Nab-paclitaxel

Drug

Administered intravenously, 180-220mg/m2 on day 2 in a 3-week cycle (day 1 without Manganese priming)

Other names: Paclitaxel For Injection (Albumin Bound)

Platinum chemotherapy

Drug

Administered intravenously, Cisplatin (60-80mg/m2) or Carboplatin (area under the curve [AUC] 4-6 mg/mL per min) on day 2 in a 3-week cycle (day 1 without Manganese priming)

Sintilimab

Drug

Administered intravenously, 200mg on day 3 in a 3-week cycle (day 2 without Manganese priming)

Other names: anti-PD-1 antibody; PD-1 inhibitor

Primary outcomes

  1. Object response rate (ORR)

    Time frame: 24 months

    ORR is defined as the proportion of subjects who achieved a partial response (PR) or complete response (CR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

  2. Number of Subjects with treatment-related adverse events (AEs)

    Time frame: 12 months

    Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0. AEs were considered to be treatment-related if they had started or worsened within the interval from first study drug administration until the follow-up visit.

Secondary outcomes

  1. Disease control rate (DCR)

    Time frame: 12 months

    DCR is defined as the proportion of subjects who achieved a stable disease (SD), partial response (PR) or complete response (CR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

  2. Progression-free survival (PFS)

    Time frame: 12 months

    PFS time was measured from study entry to the first documentation of disease progression or death. Disease progression was determined per the RECIST V1.1.

  3. Overall survival (OS)

    Time frame: 24 months

    OS time was measured from the study entry to the date of death.

  4. Number of participants with laboratory test abnormalities

    Time frame: 12 months

    The laboratory tests of serum cytokines and chemokines will be performed on day 1 and 3 of each cycle, and the abnormality will be determined by the investigator.

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Registry information

Official study title

A Randomized, Single-blind, Placebo-controlled, Phase 2 Study to Evaluate the Safety and Efficacy of the Pan-immunotherapy in Subjects With Relapsed/Refractory Ovarian Cancer

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Jun 18, 2019
Registry last updated
Jul 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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