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Trial record 2 of 204 for:    Ovarian Dysgenesis 1

An Open-label, Phase I/II Study of the Pan-immunotherapy in Patients With Relapsed/Refractory Ovarian Cancer

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ClinicalTrials.gov Identifier: NCT03989336
Recruitment Status : Recruiting
First Posted : June 18, 2019
Last Update Posted : June 18, 2019
Sponsor:
Information provided by (Responsible Party):
Han weidong, Chinese PLA General Hospital

Brief Summary:
Ovarian cancer is the most lethal gynecological cancer and the 5th leading cause of cancer death in women. Platinum-containing 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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: Manganese Chloride Drug: nab-paclitaxel Drug: Cisplatin Drug: anti-PD-1 antibody Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II, Open-label, Two-arm, Single-center Study to Evaluate the Safety and Efficacy of the Pan-immunotherapy in Subjects With Relapsed/Refractory Ovarian Cancer
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : March 31, 2021


Arm Intervention/treatment
Experimental: Manganese primed anti-PD-1 antibody plus nPC chemotherapy
Subject received Manganese primed anti-PD-1 antibody, nab-paclitaxel and cisplatin every 3 weeks until achieving a second assessable objective response or up to a maximum of 12 cycles. Treatment continued until progressive disease, development of unacceptable toxicity, or withdrawal of consent.
Drug: Manganese Chloride
Administered by inhalation at 0.2 or 0.4mg/kg/d once daily in a 3-week cycle

Drug: nab-paclitaxel
Administered intravenously, 180-220mg/m2 on day 2 in a 3-week cycle (day 1 without Manganese priming)
Other Name: Paclitaxel For Injection (Albumin Bound)

Drug: Cisplatin
Administered intravenously, 60-80mg/m2 on day2 in a 3-week cycle (day 1 without Manganese priming)

Drug: anti-PD-1 antibody
Administered intravenously, 2-4mg/kg on day 3 in a 3-week cycle (day 2 without Manganese priming)
Other Name: Anti-PD-1 monoclonal antibody; PD-1 inhibitor

Experimental: anti-PD-1 antibody plus nPC chemotherapy
Subject received anti-PD-1 antibody, nab-paclitaxel and cisplatin every 3 weeks until achieving a second assessable objective response or up to a maximum of 12 cycles. Treatment continued until progressive disease, development of unacceptable toxicity, or withdrawal of consent.
Drug: nab-paclitaxel
Administered intravenously, 180-220mg/m2 on day 2 in a 3-week cycle (day 1 without Manganese priming)
Other Name: Paclitaxel For Injection (Albumin Bound)

Drug: Cisplatin
Administered intravenously, 60-80mg/m2 on day2 in a 3-week cycle (day 1 without Manganese priming)

Drug: anti-PD-1 antibody
Administered intravenously, 2-4mg/kg on day 3 in a 3-week cycle (day 2 without Manganese priming)
Other Name: Anti-PD-1 monoclonal antibody; PD-1 inhibitor




Primary Outcome Measures :
  1. 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.

  2. Object response rate (ORR) [ Time Frame: 12 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.


Secondary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 within 6 months 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.

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): NCT03989336


Contacts
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Contact: Weidong Han 01066937463 hanwdrsw@sina.com

Locations
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China, Beijing
Biotherapeutic Department of Chinese PLA General Hospital Recruiting
Beijing, Beijing, China, 100853
Contact: Weidong Han, M.D    +86-10-66937463    hanwdrsw@sina.com   
Contact: Qingming Yang, M.D    +86-10-55499341    yangqm301@163.com   
Principal Investigator: Weidong Han, M.D         
Principal Investigator: Qian Mei, M.D         
Principal Investigator: Qingming Yang, M.D         
Principal Investigator: Yan Zhang, M.S.         
Sub-Investigator: Meixia Chen, M.S.         
Sub-Investigator: Yuanguang Meng, M.D.         
Sub-Investigator: Kaichao Feng, M.S.         
Sub-Investigator: Yang Liu, M.D.         
Sub-Investigator: Jiejie Liu, B.S.         
Sub-Investigator: Xiang Li, B.S.         
Sub-Investigator: Liang Dong, M.D.         
Sponsors and Collaborators
Chinese PLA General Hospital

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Responsible Party: Han weidong, Professor, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT03989336     History of Changes
Other Study ID Numbers: CHN-PLAGH-BT-040
First Posted: June 18, 2019    Key Record Dates
Last Update Posted: June 18, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Han weidong, Chinese PLA General Hospital:
relapsed
refractory
anti-PD-1 antibody
Manganese
chemotherapy
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Ovarian Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Manganese
Paclitaxel
Albumin-Bound Paclitaxel
Cisplatin
Antibodies
Immunoglobulins
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs
Trace Elements