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

NCT ID: NCT03989336

Last Updated: 2024-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-23
• Study Completion Date: 2023-12-10

Brief Summary

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.

Conditions

Ovarian Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Manganese primed Sintilimab plus nPP chemotherapy

Subject received Manganese primed Sintilimab, nab-paclitaxel and platinum chemotherapy every 3 weeks until achieving a second assessable complete response or progressive disease, development of unacceptable toxicity, or withdrawal of consent.

Group Type: EXPERIMENTAL

Manganese Chloride

Intervention Type: 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

Intervention Type: DRUG

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

Platinum chemotherapy

Intervention Type: 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

Intervention Type: DRUG

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

Sintilimab plus nPP chemotherapy

Subject received Sintilimab, nab-paclitaxel and platinum chemotherapy every 3 weeks until achieving a second assessable complete response or progressive disease, development of unacceptable toxicity, or withdrawal of consent.

Group Type: ACTIVE_COMPARATOR

nab-paclitaxel

Intervention Type: DRUG

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

Platinum chemotherapy

Intervention Type: 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

Intervention Type: DRUG

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

Interventions

Manganese Chloride

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

Intervention Type: DRUG

nab-paclitaxel

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

Intervention Type: DRUG

Platinum chemotherapy

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)

Intervention Type: DRUG

Sintilimab

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

Intervention Type: DRUG

Other Intervention Names

Paclitaxel For Injection (Albumin Bound); anti-PD-1 antibody; PD-1 inhibitor

Eligibility Criteria

Inclusion Criteria

1. 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.

2. Female.

3. ≥ 18 years old.

4. Life expectancy of at least 6 months.

5. Eastern Cooperative Oncology Group performance status 0-2.

6. 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.

7. Subjects must have received at least two frontline therapies, at least one of which is platinum-containing.

8. Subjects with Anti-PD-1 antibody treatment history are eligible which must be resistance.

9. Adequate organ function.

10. 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

1. Subjects with any autoimmune disease or history of syndrome that requires corticosteroids or immunosuppressive medications.

2. Serious uncontrolled medical disorders or active infections, pulmonary infection especially.

3. Prior organ allograft.

4. Women who are pregnant or breastfeeding.

5. Women with a positive pregnancy test on enrollment or prior to investigational product administration.

6. Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.

7. Subjects with previous or concurrent other malignancies.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Chinese PLA General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Han weidong

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Biotherapeutic Department of Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

CHN-PLAGH-BT-040

Identifier Type: -

Identifier Source: org_study_id