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

Phase 1

Completed

• Conditions: Malignant Solid Tumour
• Interventions: Drug: Pembrolizumab; Biological: NK immunotherapy

• Registration Number: NCT02843204
• Lead Sponsor: 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.

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).

Study Timeline

• Study Start: 2016-07-01
• Study First Submitted: 2016-07-21
• Study First Submitted QC: 2016-07-22
• Study First Posted: 2016-07-25
• Primary Completion: 2017-07-01
• Study Completion: 2019-07-01
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-26
• Last Update Posted: 2020-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pembrolizumab and NK immunotherapy	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 and NK immunotherapy	Pembrolizumab	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	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).

Primary Outcome Measures

Name	Time	Method
PFS	2 year	PFS was defined as the interval between treatment initiation and local relapse,
OS	3 years	OS was calculated as the interval from treatment initiation to death.

Secondary Outcome Measures

Name	Time	Method
CTC	3 months	The absolute number of CD45-CK+ CD326+ cells was used to quantitate the CTC levels.
PD-1	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
Tumor size	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).
CEA	3 months	CEA was evaluated by a chemiluminescent immunoassay before treatment and 90 days after treatment.

Trial Locations

Locations (1)

Cancer Institute in Fuda Cancer Hospital; 🇨🇳 Guangzhou, Guangdong, China