Combination of Anti-PD-1 and NK Immunotherapy for Recurrent Solid Tumors
NCT ID: NCT02843204
Last Updated: 2020-05-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
110 participants
INTERVENTIONAL
2016-07-01
2019-07-01
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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).
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
NK immunotherapy
Each treatment: about 10 billion cells in all, infusion in 3 times, i.v.
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).
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
Interventions
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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
NK immunotherapy
Each treatment: about 10 billion cells in all, infusion in 3 times, i.v.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
70 Years
ALL
No
Sponsors
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Shenzhen Hank Bioengineering Institute
OTHER
Fuda Cancer Hospital, Guangzhou
OTHER
Responsible Party
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Principal Investigators
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Jibing Chen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Fuda Cancer Hospital, Guangzhou
Locations
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Cancer Institute in Fuda Cancer Hospital
Guangzhou, Guangdong, China
Countries
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References
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Lin M, Luo H, Liang S, Chen J, Liu A, Niu L, Jiang Y. Pembrolizumab plus allogeneic NK cells in advanced non-small cell lung cancer patients. J Clin Invest. 2020 May 1;130(5):2560-2569. doi: 10.1172/JCI132712.
Other Identifiers
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NK-PD-1
Identifier Type: -
Identifier Source: org_study_id
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