Renal Cancer MetastaticPhase 2NCT03736330
A Study of Anti-PD-1 Combinations of D-CIK Immunotherapy and Axitinib in Advanced Ranal Carcinoma
A Phase 2 study testing Combinations treatment in people with Renal Cancer Metastatic, run by Sun Yat-sen University at 1 site in China.
Trial summary
Phase II clinical trial to investigate the safety, clinical activity and toxicity of combinations of D-CIK and low dose anti-PD-1 antibody in patients with metastatic renal cell carcinoma treated with axitinib. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Renal Cancer Metastatic
- What is being tested?
- Combinations treatment
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 8 Sep 2018to 8 Nov 2021
- Phase
- Phase 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- advanced renal clear cell carcinoma confirmed by pathology: high-volume disease without systemic treatment(including primary lesion unable to surgery, multiple lymph node metastases or distant metastases), or achieved disease progression after treatment by the anti-angiogenesis therapy (TKI or mTOR inhibitors) or by cytokines or combination therapy
- Predicted survival >=3 months
- At least 1 measurable lesion
- High-volume disease（meet one of the following criteria）:1. More than 3 sites of lesions with or without primary lesions, and at least 1 lesion routine CT or spiral CT scan >=3cm; 2. Unresected primary lesions (> 10cm), accompanied by 2 metastatic lesions; 3. After nephrectomy, single metastasis, at least 3 metastases, and at least one lesion > 2cm; 4. After nephrectomy, multiple metastatic(>3 organs) and at least one lesion > 2cm.
Who cannot join
- Prior treatment with anti-PD-1/PD-L1/PD-L2 antibody and Axitinib
- Hypersensitivity to recombinant humanized anti-PD-1 monoclonal Abm or its components
- Severe cardiovascular and cerebrovascular diseases, uncontrollable severe hypertension and diabetes, severe renal insufficiency or uremia
- Long-term use of immunosuppressive agents after organ transplantation
- Immunosuppressive drugs are currently in use
- People with a clear and serious infection
Show all 11Show fewer
- Predicted survival<3 months
- Patients with T cell lymphoma, myeloma
- Patients with autoimmune diseases
- HIV positive, or other immunodeficiency diseases
- Pregnant or nursing
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060
Fang-Jian Zhou, M.D Ph.D, zhoufj@sysucc.org.cn
Zhi-Ling Zhang, M.D Ph.D, zhangzhl@sysucc.org.cn
About this study
Official title: A Study of Anti-PD-1( Pembrolizumab) Combinations of D-CIK (Cytokine-induced Killer Cells Are Stimulated Using Mature Dendritic Cells) Immunotherapy and Axitinib in Advanced Ranal Carcinoma
Phase II clinical trial to investigate the safety, clinical activity and toxicity of combinations of D-CIK and low dose anti-PD-1 antibody in patients with metastatic renal cell carcinoma treated with axitinib.
Read the detailed description
This is a phase II, single arm study to investigate the safety and efficacy of pembrolizumab-activated autologous D-CIK cells (CIK:Cytokine-induced killer, D-CIK:CIK cells are stimulated using mature dendritic cells) with Axitinib in patients with advanced kidney cancer.
Heparinized peripheral blood was obtained from participants over a 1-week period. PBMCs(Peripheral blood mononuclear cells) were separated by Ficoll-Hypaque gradient centrifugation, suspended in X-VIVO 15 serum-free medium, and culture with 1000 U/ml rhIFN-γfor the first 24 h, followed by stimulation with 100 ng/ml OKT-3 , 1000 U/ml rhIL-2 and 100 U/ml IL-1α to activate the CIK.Dendritic cells were incubated with CIK. Fresh medium containing 1000 U/ml rhIL-2 was added every 2 days and the cell density was maintained at 2×10^6 cells/mL.D-CIK were harvested, washed, and resuspended after culture for 14 days. Before cell transfer,D-CIK were incubated with anti-PD-1 antibody(Pembrolizumab (Merck \& Co., Inc.) is a humanized IgG4 anti-PD-1 monoclonal antibody that binds to PD-1 to prevent it from engaging with PD-L1 or PD-L2.), and a fraction of the D-CIK were collected to assess their number, phenotype, and viability of cells, and to test for possible contamination by bacteria, fungi, or endotoxins. Then, autologous D-CIK (1.0-1.5*10^10 cells) were transferred to patients via intravenous infusion.
The present study was designed with Simon's best two stage study to explore the efficacy and safety of low-dose pembrolizumab in the treatment of patients with advanced renal cancer by D-CIK re-transfusion combined with Axitinib in vitro. The expected effective rate of the combined treatment is set at 60%, and if the effective rate is less than 30%, the effective rate of the combined treatment is considered to be at an undesirable level. The best two-stage design is 3/8, 10/24. In the first stage, 8 patients need to be treated. If the number of effective cases is less than 3, the combined treatment is deemed ineffective and the trial needs to be terminated. If the number of effective cases is more than 3, the phase II trial will be continued, and a total of 24 subjects need to be included.
- Conditions
- Renal Cancer Metastatic
- Being tested
- Combinations treatment
- Keywords
- Ranal Carcinoma, Immunotherapy, Axitinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combinations treatmentBiological
Also called pembrolizumab(Merck & Co., Inc.)
Autologous dendritic and cytokine-induced killer cells (D-CIK)(1.0-1.5*10^10 cells)were incubated with low dose anti-PD-1 antibody（pembrolizumab, Merck \& Co., Inc.） and were transferred to participants via intravenous infusion .
| Study group | Role | What they receive |
|---|---|---|
| Combinations treatment | Experimental | Drug: Axitinib 5mg orally twice a day Combination Treatment：Anti-PD-1 Combinations of D-CIK Immunotherapy Receives: Biological: Combinations treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate（ORR）by irRC and RECIST 1.1
The treatment effect of Anti-PD-1 combinations of D-CIK immunotherapy and axitinib,will be assessed using irRC and RECIST 1.1 to determine tumor response.
Measured: 3 years
Secondary outcomes (5)
Progression-free Survival（PFS）by irRC and RECIST 1.1
The treatment effect of Anti-PD-1 combinations of D-CIK immunotherapy and axitinib, will be assessed using irRC and RECIST 1.1 to determine progression-free survival time.
Measured: 3 years
Overall Survival (OS) by irRC and RECIST 1.1
The treatment effect of Anti-PD-1 combinations of D-CIK immunotherapy and axitinib, will be assessed using irRC and RECIST 1.1 to determine overall survival time.
Measured: 3 years
Duration of Response (DOR) by irRC and RECIST 1.1
The treatment effect of Anti-PD-1 combinations of D-CIK immunotherapy and axitinib, will be assessed using irRC and RECIST 1.1 to determine duration of response.
Measured: 3 years
The quality of life by EQ-5D-5L and NCCN-FACT FKSI-19 v2.0.
The treatment effect of Anti-PD-1 combinations of D-CIK immunotherapy and axitinib, will be assessed using EQ-5D-5L and NCCN-FACT FKSI-19 v2.0.to determine the quality of life.
Measured: 3 years
Severity of adverse events as assessed by CTCAE v4.0
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2018
- Study start8 Sep 2018
- Primary completion8 Oct 2020 (estimated)
- Study completion8 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Renal Cancer MetastaticStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Autologous D-CIK (1.0-1.5\*10\^10 cells) will be transferred to patients via intravenous infusion. Before cell transfer, D-CIK were incubated with anti-PD-1 antibody.
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ZHOU FANGJIAN, Sun Yat-sen University
- Investigators
- Fangjian Zhou, MD.PhD, Principal investigator, Director of Urology,Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03736330
- Sponsor's protocol ID
- 2017-FXY-023-Urology
- Status last verified
- Nov 2018
- First submitted
- 1 Nov 2018
- Last updated
- 9 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We did not decide whether to share the subject's personal information
Publications
Rini BI, Escudier B, Tomczak P, Kaprin A, Szczylik C, Hutson TE, Michaelson MD, Gorbunova VA, Gore ME, Rusakov IG, Negrier S, Ou YC, Castellano D, Lim HY, Uemura H, Tarazi J, Cella D, Chen C, Rosbrook B, Kim S, Motzer RJ. Comparative effectiveness of axitinib versus sorafenib in advanced renal cell carcinoma (AXIS): a randomised phase 3 trial. Lancet. 2011 Dec 3;378(9807):1931-9. doi: 10.1016/S0140-6736(11)61613-9. Epub 2011 Nov 4.
PubMed 22056247Du Four S, Maenhout SK, De Pierre K, Renmans D, Niclou SP, Thielemans K, Neyns B, Aerts JL. Axitinib increases the infiltration of immune cells and reduces the suppressive capacity of monocytic MDSCs in an intracranial mouse melanoma model. Oncoimmunology. 2015 Jan 22;4(4):e998107. doi: 10.1080/2162402X.2014.998107. eCollection 2015 Apr.
PubMed 26137411Mahoney KM, Rennert PD, Freeman GJ. Combination cancer immunotherapy and new immunomodulatory targets. Nat Rev Drug Discov. 2015 Aug;14(8):561-84. doi: 10.1038/nrd4591.
PubMed 26228759Lee JH, Lee JH, Lim YS, Yeon JE, Song TJ, Yu SJ, Gwak GY, Kim KM, Kim YJ, Lee JW, Yoon JH. Adjuvant immunotherapy with autologous cytokine-induced killer cells for hepatocellular carcinoma. Gastroenterology. 2015 Jun;148(7):1383-91.e6. doi: 10.1053/j.gastro.2015.02.055. Epub 2015 Mar 4.
PubMed 25747273Chen CL, Pan QZ, Weng DS, Xie CM, Zhao JJ, Chen MS, Peng RQ, Li DD, Wang Y, Tang Y, Wang QJ, Zhang ZL, Zhang XF, Jiang LJ, Zhou ZQ, Zhu Q, He J, Liu Y, Zhou FJ, Xia JC. Safety and activity of PD-1 blockade-activated DC-CIK cells in patients with advanced solid tumors. Oncoimmunology. 2018 Jan 10;7(4):e1417721. doi: 10.1080/2162402X.2017.1417721. eCollection 2018.
PubMed 29632736
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Anti-PD-1( Pembrolizumab) Combinations of D-CIK (Cytokine-induced Killer Cells Are Stimulated Using Mature Dendritic Cells) Immunotherapy and Axitinib in Advanced Ranal Carcinoma
- ClinicalTrials.gov ID
- NCT03736330
- Acronym / sponsor ID
- 2017-FXY-023-Urology
- Conditions
- Renal Cancer Metastatic
- Keywords
- Ranal Carcinoma, Immunotherapy, Axitinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 8 Sep 2018 (actual)
- Primary completion
- 8 Oct 2020 (estimated)
- Study completion
- 8 Nov 2021 (estimated)
- First posted
- 9 Nov 2018 (actual)
- 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.
Phase II clinical trial to investigate the safety, clinical activity and toxicity of combinations of D-CIK and low dose anti-PD-1 antibody in patients with metastatic renal cell carcinoma treated with axitinib.
Detailed description
This is a phase II, single arm study to investigate the safety and efficacy of pembrolizumab-activated autologous D-CIK cells (CIK:Cytokine-induced killer, D-CIK:CIK cells are stimulated using mature dendritic cells) with Axitinib in patients with advanced kidney cancer.
Heparinized peripheral blood was obtained from participants over a 1-week period. PBMCs(Peripheral blood mononuclear cells) were separated by Ficoll-Hypaque gradient centrifugation, suspended in X-VIVO 15 serum-free medium, and culture with 1000 U/ml rhIFN-γfor the first 24 h, followed by stimulation with 100 ng/ml OKT-3 , 1000 U/ml rhIL-2 and 100 U/ml IL-1α to activate the CIK.Dendritic cells were incubated with CIK. Fresh medium containing 1000 U/ml rhIL-2 was added every 2 days and the cell density was maintained at 2×10^6 cells/mL.D-CIK were harvested, washed, and resuspended after culture for 14 days. Before cell transfer,D-CIK were incubated with anti-PD-1 antibody(Pembrolizumab (Merck \& Co., Inc.) is a humanized IgG4 anti-PD-1 monoclonal antibody that binds to PD-1 to prevent it from engaging with PD-L1 or PD-L2.), and a fraction of the D-CIK were collected to assess their number, phenotype, and viability of cells, and to test for possible contamination by bacteria, fungi, or endotoxins. Then, autologous D-CIK (1.0-1.5*10^10 cells) were transferred to patients via intravenous infusion.
The present study was designed with Simon's best two stage study to explore the efficacy and safety of low-dose pembrolizumab in the treatment of patients with advanced renal cancer by D-CIK re-transfusion combined with Axitinib in vitro. The expected effective rate of the combined treatment is set at 60%, and if the effective rate is less than 30%, the effective rate of the combined treatment is considered to be at an undesirable level. The best two-stage design is 3/8, 10/24. In the first stage, 8 patients need to be treated. If the number of effective cases is less than 3, the combined treatment is deemed ineffective and the trial needs to be terminated. If the number of effective cases is more than 3, the phase II trial will be continued, and a total of 24 subjects need to be included.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Autologous D-CIK (1.0-1.5*10^10 cells) will be transferred to patients via intravenous infusion. Before cell transfer, D-CIK were incubated with anti-PD-1 antibody.
| Arm | Type | Receives |
|---|---|---|
| Combinations treatment | Experimental | Biological: Combinations treatmentDrug: Axitinib 5mg orally twice a day Combination Treatment：Anti-PD-1 Combinations of D-CIK Immunotherapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- advanced renal clear cell carcinoma confirmed by pathology: high-volume disease without systemic treatment(including primary lesion unable to surgery, multiple lymph node metastases or distant metastases), or achieved disease progression after treatment by the anti-angiogenesis therapy (TKI or mTOR inhibitors) or by cytokines or combination therapy
- Predicted survival >=3 months
- At least 1 measurable lesion
- High-volume disease（meet one of the following criteria）:1. More than 3 sites of lesions with or without primary lesions, and at least 1 lesion routine CT or spiral CT scan >=3cm; 2. Unresected primary lesions (> 10cm), accompanied by 2 metastatic lesions; 3. After nephrectomy, single metastasis, at least 3 metastases, and at least one lesion > 2cm; 4. After nephrectomy, multiple metastatic(>3 organs) and at least one lesion > 2cm.
Key exclusion criteria (11 listed)
- Prior treatment with anti-PD-1/PD-L1/PD-L2 antibody and Axitinib
- Hypersensitivity to recombinant humanized anti-PD-1 monoclonal Abm or its components
- Severe cardiovascular and cerebrovascular diseases, uncontrollable severe hypertension and diabetes, severe renal insufficiency or uremia
- Long-term use of immunosuppressive agents after organ transplantation
- Immunosuppressive drugs are currently in use
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 |
|---|---|---|
| Combinations treatmentAlso: pembrolizumab(Merck & Co., Inc.)Autologous dendritic and cytokine-induced killer cells (D-CIK)(1.0-1.5*10^10 cells)were incubated with low dose anti-PD-1 antibody（pembrolizumab, Merck \& Co., Inc.） and were transferred to participants via intravenous infusion . | Biological | Combinations treatment |
Primary outcome
Objective Response Rate（ORR）by irRC and RECIST 1.1
Time frame: 3 years
The treatment effect of Anti-PD-1 combinations of D-CIK immunotherapy and axitinib,will be assessed using irRC and RECIST 1.1 to determine tumor response.
5 secondary outcomes
Progression-free Survival（PFS）by irRC and RECIST 1.1
Time frame: 3 years
Overall Survival (OS) by irRC and RECIST 1.1
Time frame: 3 years
Duration of Response (DOR) by irRC and RECIST 1.1
Time frame: 3 years
The quality of life by EQ-5D-5L and NCCN-FACT FKSI-19 v2.0.
Time frame: 3 years
Severity of adverse events as assessed by CTCAE v4.0
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2018.
- Results publication: PubMed 22056247Rini BI, Escudier B, Tomczak P, Kaprin A, Szczylik C, Hutson TE, Michaelson MD, Gorbunova VA, Gore ME, Rusakov IG, Negrier S, Ou YC, Castellano D, Lim HY, Uemura H, Tarazi J, Cella D, Chen C, Rosbrook B, Kim S, Motzer RJ. Comparative effectiveness of axitinib versus sorafenib in advanced renal cell carcinoma (AXIS): a randomised phase 3 trial. Lancet. 2011 Dec 3;378(9807):1931-9. doi: 10.1016/S0140-6736(11)61613-9. Epub 2011 Nov 4.
- Results publication: PubMed 26137411Du Four S, Maenhout SK, De Pierre K, Renmans D, Niclou SP, Thielemans K, Neyns B, Aerts JL. Axitinib increases the infiltration of immune cells and reduces the suppressive capacity of monocytic MDSCs in an intracranial mouse melanoma model. Oncoimmunology. 2015 Jan 22;4(4):e998107. doi: 10.1080/2162402X.2014.998107. eCollection 2015 Apr.
- Results publication: PubMed 26228759Mahoney KM, Rennert PD, Freeman GJ. Combination cancer immunotherapy and new immunomodulatory targets. Nat Rev Drug Discov. 2015 Aug;14(8):561-84. doi: 10.1038/nrd4591.
- Results publication: PubMed 25747273Lee JH, Lee JH, Lim YS, Yeon JE, Song TJ, Yu SJ, Gwak GY, Kim KM, Kim YJ, Lee JW, Yoon JH. Adjuvant immunotherapy with autologous cytokine-induced killer cells for hepatocellular carcinoma. Gastroenterology. 2015 Jun;148(7):1383-91.e6. doi: 10.1053/j.gastro.2015.02.055. Epub 2015 Mar 4.
- Results publication: PubMed 29632736Chen CL, Pan QZ, Weng DS, Xie CM, Zhao JJ, Chen MS, Peng RQ, Li DD, Wang Y, Tang Y, Wang QJ, Zhang ZL, Zhang XF, Jiang LJ, Zhou ZQ, Zhu Q, He J, Liu Y, Zhou FJ, Xia JC. Safety and activity of PD-1 blockade-activated DC-CIK cells in patients with advanced solid tumors. Oncoimmunology. 2018 Jan 10;7(4):e1417721. doi: 10.1080/2162402X.2017.1417721. eCollection 2018.
- Individual participant dataSharing planned: Undecided. We did not decide whether to share the subject's personal information
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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.
Fangjian Zhou, MD.PhD principal investigator
Director of Urology,Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Combinations treatment in people with Renal Cancer Metastatic, run by Sun Yat-sen University 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 11 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: status not confirmed, as of the sponsor's last update on 9 Nov 2018. 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 phase mean?
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fangjian Zhou, MD.PhD (86-20-87343312, zhoufj@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate（ORR）by irRC and RECIST 1.1 (time frame: 3 years). 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 NCT03736330, which also lists 5 linked publications.
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 9 Nov 2018.