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

NCT02843204 | Completed Phase 1

• 1 other identifier: NK-PD-1
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Malignant Solid Tumour

Keywords

Solid tumor; Anti-PD-1; NK immunotherapy

Outcome Measures

Primary Outcomes (2)

• PFS

  PFS was defined as the interval between treatment initiation and local relapse,

  2 year

• OS

  OS was calculated as the interval from treatment initiation to death.

  3 years

Secondary Outcomes (4)

• PD-1

  3 months

• Tumor size

  3 months

• CEA

  3 months

• CTC

  3 months

Study Arms (2)

Pembrolizumab and NK immunotherapy

EXPERIMENTAL

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; Biological: NK immunotherapy

Pembrolizumab

ACTIVE COMPARATOR

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

Interventions

Pembrolizumab DRUG

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

Also known as: Keytruda

Pembrolizumab; Pembrolizumab and NK immunotherapy

NK immunotherapy BIOLOGICAL

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

Pembrolizumab and NK immunotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fuda Cancer Hospital, Guangzhou: lead
• Shenzhen Hank Bioengineering Institute: collaborator

Study Sites (1)

Cancer Institute in Fuda Cancer Hospital

Guangzhou, Guangdong, 510665, China

Location

Related Publications (1)

• 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.

  PMID: 32027620 DERIVED

MeSH Terms

Interventions

pembrolizumab

Study Officials

• Jibing Chen, MD, PhD

  Fuda Cancer Hospital, Guangzhou

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2016
• First Posted: July 25, 2016
• Study Start: July 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2019
• Last Updated: May 28, 2020

Record last verified: 2020-05

Locations

CN (1)