Malignant Solid TumourPhase 1/2NCT02843204
Combination of Anti-PD-1 and NK Immunotherapy for Recurrent Solid Tumors
A Phase 1/2 study testing Pembrolizumab and NK immunotherapy in people with Malignant Solid Tumour, run by Fuda Cancer Hospital, Guangzhou at 1 site in China.
Trial summary
The aim of this study is the safety and efficacy of anti-PD-1 plus NK immunotherapy to multiple solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Malignant Solid Tumour
- What is being tested?
- Pembrolizumab and NK immunotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2016to 1 Jul 2019
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Cancer Institute in Fuda Cancer Hospital
Guangzhou, Guangdong, 510665
About this study
The aim of this study is the safety and efficacy of anti-PD-1 plus NK immunotherapy to multiple solid tumors.
Read the 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).
- Conditions
- Malignant Solid Tumour
- Being tested
- Pembrolizumab, NK immunotherapy
- Keywords
- Solid tumor, Anti-PD-1, NK immunotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabDrug
Also called Keytruda
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 immunotherapyBiological
Each treatment: about 10 billion cells in all, infusion in 3 times, i.v.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
PFS was defined as the interval between treatment initiation and local relapse,
Measured: 2 year
OS
OS was calculated as the interval from treatment initiation to death.
Measured: 3 years
Secondary outcomes (4)
PD-1
Peripheral blood (6 mL) was obtained from healthy donors and patients before treatment and 90 days after treatment for the detection of PD-1
Measured: 3 months
Tumor size
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).
Measured: 3 months
CEA
CEA was evaluated by a chemiluminescent immunoassay before treatment and 90 days after treatment.
Measured: 3 months
CTC
The absolute number of CD45-CK+ CD326+ cells was used to quantitate the CTC levels.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2016 (estimated)
- Study start1 Jul 2016
- Primary completion1 Jul 2017
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malignant Solid TumourStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fuda Cancer Hospital, Guangzhou
- Sponsor type
- University, hospital or other
- Collaborators
- Shenzhen Hank Bioengineering Institute
- Responsible party
- Sponsor
- Investigators
- Jibing Chen, MD, PhD, Principal investigator, Fuda Cancer Hospital, Guangzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02843204
- Sponsor's protocol ID
- NK-PD-1
- Status last verified
- May 2020
- First submitted
- 21 Jul 2016
- Last updated
- 28 May 2020
- Results posted
- No
Publications
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.
PubMed 32027620
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination of Anti-PD-1 and NK Immunotherapy for Recurrent Solid Tumors
- ClinicalTrials.gov ID
- NCT02843204
- Acronym / sponsor ID
- NK-PD-1
- Conditions
- Malignant Solid Tumour
- Keywords
- Solid tumor, Anti-PD-1, NK immunotherapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Fuda Cancer Hospital, GuangzhouUniversity, hospital or other
- Collaborators
- Shenzhen Hank Bioengineering Institute
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 1 Jul 2017 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 25 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pembrolizumab and NK immunotherapy | Experimental | Drug: Pembrolizumab, Biological: NK immunotherapyIn 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 | Active comparator | Drug: PembrolizumabIn 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). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PembrolizumabAlso: KeytrudaPatients 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 | Drug | Pembrolizumab, Pembrolizumab and NK immunotherapy |
| NK immunotherapyEach treatment: about 10 billion cells in all, infusion in 3 times, i.v. | Biological | Pembrolizumab and NK immunotherapy |
Primary outcome
PFS
Time frame: 2 year
PFS was defined as the interval between treatment initiation and local relapse,
OS
Time frame: 3 years
OS was calculated as the interval from treatment initiation to death.
4 secondary outcomes
PD-1
Time frame: 3 months
Tumor size
Time frame: 3 months
CEA
Time frame: 3 months
CTC
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2020.
- Derived from this study: PubMed 32027620Lin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jibing Chen, MD, PhD principal investigator
Fuda Cancer Hospital, Guangzhou
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Pembrolizumab and NK immunotherapy in people with Malignant Solid Tumour, run by Fuda Cancer Hospital, Guangzhou at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: 2 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02843204, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2020.