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Combination of Anti-PD-1 and NK Immunotherapy for Recurrent Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02843204
Recruitment Status : Completed
First Posted : July 25, 2016
Last Update Posted : May 28, 2020
Sponsor:
Collaborator:
Shenzhen Hank Bioengineering Institute
Information provided by (Responsible Party):
Fuda Cancer Hospital, Guangzhou

Brief Summary:
The aim of this study is the safety and efficacy of anti-PD-1 plus NK immunotherapy to multiple solid tumors.

Condition or disease Intervention/treatment Phase
Malignant Solid Tumour Drug: Pembrolizumab Biological: NK immunotherapy Phase 1 Phase 2

Detailed Description:

By enrolling patients with solid tumors adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of the combined therapy using anti-PD-1 and natural killer (NK) cells.

The safety will be evaluated by statistics of adverse reactions. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Combination of Anti-PD-1 and NK Immunotherapy for Recurrent Solid Tumors
Actual Study Start Date : July 1, 2016
Actual Primary Completion Date : July 1, 2017
Actual Study Completion Date : July 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pembrolizumab and NK immunotherapy
In this group, the patients will receive regular Pembrolizumab first to control tumor burden; then NK immunotherapy will be given. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).
Drug: Pembrolizumab
Patients received i.v. pembrolizumab (10 mg/kg) on day 1 of a 21-day cycle, until disease progression, discontinuation due to unacceptable toxicity, withdrawal of consent or study closure
Other Name: Keytruda

Biological: NK immunotherapy
Each treatment: about 10 billion cells in all, infusion in 3 times, i.v.

Active Comparator: Pembrolizumab
In this group, the patients will receive regular Pembrolizumab to control tumor burden. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).
Drug: Pembrolizumab
Patients received i.v. pembrolizumab (10 mg/kg) on day 1 of a 21-day cycle, until disease progression, discontinuation due to unacceptable toxicity, withdrawal of consent or study closure
Other Name: Keytruda




Primary Outcome Measures :
  1. PFS [ Time Frame: 2 year ]
    PFS was defined as the interval between treatment initiation and local relapse,

  2. OS [ Time Frame: 3 years ]
    OS was calculated as the interval from treatment initiation to death.


Secondary Outcome Measures :
  1. PD-1 [ Time Frame: 3 months ]
    Peripheral blood (6 mL) was obtained from healthy donors and patients before treatment and 90 days after treatment for the detection of PD-1

  2. Tumor size [ Time Frame: 3 months ]
    The tumor responses of the enrolled patients were assessed by CT in accordance with RECIST v1.1.Institute Common Terminology Criteria for Adverse Events (v4.0).

  3. CEA [ Time Frame: 3 months ]
    CEA was evaluated by a chemiluminescent immunoassay before treatment and 90 days after treatment.

  4. CTC [ Time Frame: 3 months ]
    The absolute number of CD45-CK+ CD326+ cells was used to quantitate the CTC levels.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies after cancer recurrence
  • Progression after chemotherapy or appropriate TKI treatment for those patients with an EGFR-sensitizing mutation or ALK rearrangement
  • KPS ≥ 70, lifespan > 3 months, PD-L1 TPS of 1% or greater
  • Platelet count ≥ 80×10^9/L,white blood cell count ≥ 3×10^9/L, neutrophil count ≥ 2×10^9/L, hemoglobin ≥ 80 g/L

Exclusion Criteria:

  • Patients with cardiac pacemaker
  • Patients with brain metastasis
  • Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction, myelosuppression, autoimmune disease, pneumonitis
  • Previous treatment with a therapeutic antibody against CTLA4, PD-L1, or PD-1, or PD-L1/PD-1 pathway-targeting agents.

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): NCT02843204


Locations
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China, Guangdong
Cancer Institute in Fuda Cancer Hospital
Guangzhou, Guangdong, China, 510665
Sponsors and Collaborators
Fuda Cancer Hospital, Guangzhou
Shenzhen Hank Bioengineering Institute
Investigators
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Principal Investigator: Jibing Chen, MD, PhD Fuda Cancer Hospital, Guangzhou
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Fuda Cancer Hospital, Guangzhou
ClinicalTrials.gov Identifier: NCT02843204    
Other Study ID Numbers: NK-PD-1
First Posted: July 25, 2016    Key Record Dates
Last Update Posted: May 28, 2020
Last Verified: May 2020
Keywords provided by Fuda Cancer Hospital, Guangzhou:
Solid tumor
Anti-PD-1
NK immunotherapy
Additional relevant MeSH terms:
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Neoplasms
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents