Kidney Cancer Stage IvPhase 1NCT03086174

Tolerability and Pharmacokinetics of Toripalimab in Combination With Axitinib in Patients With Kidney Cancer and Melanoma

A Phase 1 study testing humanized anti-PD-1 monoclonal antibody Toripalimab in people with Kidney Cancer Stage Iv and Advanced Melanoma, run by Shanghai Junshi Bioscience Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

This is a phase Ib, open, mono-center, dose-escalation, tolerability and pharmacokinetic study evaluating the Recombinant Humanized Anti-PD-1 mAb for Injection in combination with Axitinib in patients with advanced kidney cancer and melanoma who have failed in routine systemic treatment. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Kidney Cancer Stage Iv, Advanced Melanoma
What is being tested?: humanized anti-PD-1 monoclonal antibody Toripalimab
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: 31 Mar 2017to Dec 2020
Phase: Phase 1
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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male and Female aged between 18 and 75 years are eligible;
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
At least received first-line treatment but appeared disease progression or intolerance, and a diagnosis of an advanced kidney Cancer and melanoma confirmed by pathology (Remark: Treatment intolerance including 1) The main organ function of the patient is evaluated by the doctor that can not be treated by the first-line standard;2) Patients received a first-line treatment with a 3/4 adverse reaction;3) Patients reject first-line treatment, etc)
Providing with tumor specimen (for testing the expression of PD -L1 and the infiltrating lymphocytes);
At least 1 measurable lesion (only 1 measurable lymph node lesion is excluded) (routine CT scan >=20mm, spiral CT scan >=10mm, no prior radiation to measurable lesions)
Predicted survival >=3 months;

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Brain or meningeal metastases must be disposed with surgery or radiation, and be stable clinically for at least 3 months (prior systemic steroids was allowed, but concurrent administration of systemic steroids with the study drug is excluded).
Screening laboratory values must meet the following criteria（within past 14 days）:
hemoglobin ≥ 9.0 g/dL; neutrophils ≥ 1500 cells/ µL; platelets ≥ 100 x 10^3/ µL; total bilirubin ≤ 1.5 x upper limit of normal (ULN); aspartic transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x ULN without, and ≤ 5 x ULN with hepatic metastasis; serum creatinine ≤1╳ULN，creatinine clearance >50ml/min (Cockcroft-Gault equation) INR, aPTT≤1.5 x ULN; Urine protein + 1 or less, if the urine protein > 1 +, need to collect 24 hours urinary protein determination, the total amount should be 1 gram or less
Without systemic steroids within past 4 weeks
Males or female of childbearing potential must: agree to use using a reliable form of contraception (eg, oral contraceptives, intrauterine device, control sex desire, double barrier method of condom and spermicidal) during the treatment period and for at least 12 months after the last dose of study drug.
Must have read, understood, and provided written informed consent voluntarily. Willing to adhere to the study visit schedule and the prohibitions and restrictions specified in this protocol.

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
Prior antitumor therapy (including corticosteroids and immunotherapy) or participation in other clinical trials within past 4 weeks, or have not recovered from toxicities since the last treatment;
Pregnant or nursing;
Positive tests for HIV, HCV, HBsAg or HBcAb with positive test for HBV DNA (>500IU/ml);
HBsAg or HBcAb with positive test for HBV DNA (>500IU/ml)

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History with active tuberculosis;
Associated with clinical symptoms or symptomatic treatment of pleural effusion or ascites;
Patients with any active autoimmune disease or a documented history of autoimmune disease, or history of syndrome that required systemic steroids or immunosuppressive medications, such as hypophysitis, pneumonia, colitis, hepatitis, nephritis, hyperthyroidism or hypothyroidism;
Severe, uncontrolled medical condition that would affect patients' compliance or obscure the interpretation of toxicity determination or adverse events, including active severe infection, uncontrolled diabetes, angiocardiopathy (heart failure > class II NYHA, heart block >II grade, myocardial infarction, unstable arrhythmia or unstable angina within past 6 months, cerebral infarction within past 3 months) or pulmonary disease ( interstitial pneumonia, obstructive pulmonary disease or symptomatic bronchospasm).
Evidence with active CNS disease;
Prior treatment with bone marrow stimulating factors，such as CSF (colony stimulating factor), EPO (erythropoietin), within past 1 weeks;
Prior live vaccine therapy within past 4 weeks;
Received allogeneic hematopoietic stem cell transplantation or solid organ transplantation;
Prior major surgery within past 4 weeks (diagnostic surgery excluded).
Psychiatric medicines abuse without withdrawal, or history of psychiatric illness.
Prior malignancy active within the previous 5 years except for locally curable cancers that have been apparently cured, such as basal cell skin cancer or carcinoma in situ of the cervix.
Underlying medical condition that, in the Investigator's opinion, would increase the risks of study drug administration or obscure the interpretation of toxicity determination or adverse events.

Trial locations and contacts

1 site in 1 country.

China1 site

Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142

Other trials in China

About this study

Official title: A Phase Ib,Open,Mono-center,Dose-escalation,Tolerability and Pharmacokinetic Study of Recombinant Humanized Anti-PD-1 mAb for Injection in Combination With Axitinib in Patients With Advanced Kidney Cancer and Melanoma

Read the detailed description

18 to 24 patients will be enrolled in dose escalation part.This part is to analyze safety and efficacy of the humanized anti-PD-1 antibody in combination with axitinib and to confirm dose-limiting toxicity (DLT), maximum tolerated dose (MTD) and recommended dose (RD). After finishing the dose escalation part, we will enroll other patients for each tumor types of recommended dose group to ensure each group have 10 patients. This part is to further analyze safety and efficacy of the humanized anti-PD-1 antibody.

Conditions: Kidney Cancer Stage Iv, Advanced Melanoma
Being tested: humanized anti-PD-1 monoclonal antibody Toripalimab
Keywords: anti-PD-1 monoclonal antibody, advanced, melanoma, kidney cancer
Medical subject headings: Kidney Neoplasms, Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

humanized anti-PD-1 monoclonal antibody ToripalimabBiological
Also called JS001, TAB001
humanized anti-PD-1 monoclonal antibody Toripalimab is a programmed death-1 (PD-1) immune checkpoint inhibitor antibody, which selectively interferes with the combination of PD-1 with its ligands, PD-L1 and PD-L2, resulting in the activation of lymphocytes and elimination of malignancy theoretically.

Study groups in NCT03086174
Study group	Role	What they receive
humanized anti-PD-1monoclonal antibody	Experimental	humanized anti-PD-1 monoclonal antibody is to be injected intravenously 1mg/kg or 3mg/kg Q2w PLUS axitinib 5 mg orally Q2w until disease progresses or unacceptable tolerability occurs Receives: Biological: humanized anti-PD-1 monoclonal antibody Toripalimab

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Safety assessments including vital signs, laboratory tests, and adverse event monitoring
Measured: 3 years

Secondary outcomes (17)

PD-1 receptor occupancy of blood
To test the PD - 1 receptor share in the blood
Measured: 3 years
Objective Response Rate (ORR) by irRC and RECIST 1.1
The treatment effect of JS001 in combination with axitinib, will be assessed using irRC and RECIST 1.1 to determine tumor response.
Measured: 3 years
Duration of Response (DOR) by irRC and RECIST 1.1
The treatment effect of JS001 in combination with axitinib, will be assessed using irRC and RECIST 1.1 to determine duration of response.
Measured: 3 years
Disease Control Rate (DCR) by irRC and RECIST 1.1
The treatment effect of JS001 in combination with axitinib, will be assessed using irRC and RECIST 1.1 to determine disease control rate.
Measured: 3 years
Time to response (TTR) by irRC and RECIST 1.1
The treatment effect of JS001 in combination with axitinib, will be assessed using irRC and RECIST 1.1 to determine time to response.
Measured: 3 years
Progression-free survival(PFS) by irRC and RECIST 1.1
The treatment effect of JS001 in combination with 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 JS001 in combination with axitinib, will be assessed using irRC and RECIST 1.1 to determine overall survival.
Measured: 3 years
PK Parameter: Maximum Plasma Concentration (Cmax)
Maximum Plasma Concentration (Cmax) after single dose injection of Anti-PD-1 Monoclonal Antibody (mAb) in combination with axitinib
Measured: 3 years
PK Parameter: Peak Time (Tmax)
Peak Time (Tmax) after single dose injection of Anti-PD-1 mAb in combination with axitinib
Measured: 3 years
PK Parameter: t1/2
t1/2 after single dose injection of Recombinant Humanized Anti-PD-1 mAb in combination with axitinib
Measured: 3 years
PK Parameter: Area Under the Curve (AUC)
Area Under the Curve (AUC) after single dose injection of Anti-PD-1 mAb in combination with axitinib
Measured: 3 years
PK Parameter: Plasma clearance (CL)
Plasma clearance (CL) after single dose injection of Anti-PD-1 mAb in combination with axitinib
Measured: 3 years
PK Parameter: Apparent volume of distribution (V)
Apparent volume of distribution (V) after single dose injection of Anti-PD-1 mAb in combination with axitinib
Measured: 3 years
PK Parameter: Minimum Plasma Concentration (Cmin)
Minimum Plasma Concentration (Cmin) of steady state after multiple dose injection of Anti-PD-1 mAb in combination with axitinib
Measured: 3 years
PK Parameter: Average Plasma Concentration (Cav)
Average Plasma Concentration (Cav) of steady state after multiple dose injection of Anti-PD-1 mAb in combination with axitinib
Measured: 3 years
PK Parameter: degree of fluctuation (DF)
degree of fluctuation (DF) of steady state after multiple dose injection of Anti-PD-1 mAb in combination with axitinib
Measured: 3 years
PK Parameter: Apparent volume of distribution of steady state (Vss)
Apparent volume of distribution of steady state (Vss) after multiple dose injection of Anti-PD-1 mAb in combination with axitinib
Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Mar 2017Dec 2020

First posted22 Mar 2017
Study start31 Mar 2017
Primary completion31 Dec 2019
Study completionDec 2020 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Kidney Cancer Stage IvStudies 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
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 24 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03086174
Sponsor's protocol ID: Junshi-JS001-008
Status last verified: Sep 2020
First submitted: 9 Mar 2017
Last updated: 30 Sep 2020
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes

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 22056247
Du 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 26137411
Li S, Wu X, Yan X, Zhou L, Chi Z, Si L, Cui C, Tang B, Mao L, Lian B, Wang X, Bai X, Dai J, Kong Y, Tang X, Feng H, Yao S, Flaherty KT, Guo J, Sheng X. Toripalimab plus axitinib in patients with metastatic mucosal melanoma: 3-year survival update and biomarker analysis. J Immunother Cancer. 2022 Feb;10(2):e004036. doi: 10.1136/jitc-2021-004036.
PubMed 35193932

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Kidney Cancer Stage Iv trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase Ib,Open,Mono-center,Dose-escalation,Tolerability and Pharmacokinetic Study of Recombinant Humanized Anti-PD-1 mAb for Injection in Combination With Axitinib in Patients With Advanced Kidney Cancer and Melanoma
ClinicalTrials.gov ID: NCT03086174
Acronym / sponsor ID: Junshi-JS001-008
Conditions: Kidney Cancer Stage Iv, Advanced Melanoma
Keywords: anti-PD-1 monoclonal antibody, advanced, melanoma, kidney cancer
Phase: Phase 1
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 24 participants (estimated)
Lead sponsor: Shanghai Junshi Bioscience Co., Ltd.University, hospital or other
Study start: 31 Mar 2017 (actual)
Primary completion: 31 Dec 2019 (actual)
Study completion: Dec 2020 (estimated)
First posted: 22 Mar 2017 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
humanized anti-PD-1monoclonal antibody	Experimental	Biological: humanized anti-PD-1 monoclonal antibody Toripalimabhumanized anti-PD-1 monoclonal antibody is to be injected intravenously 1mg/kg or 3mg/kg Q2w PLUS axitinib 5 mg orally Q2w until disease progresses or unacceptable tolerability occurs

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

Male and Female aged between 18 and 75 years are eligible;
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
At least received first-line treatment but appeared disease progression or intolerance, and a diagnosis of an advanced kidney Cancer and melanoma confirmed by pathology (Remark: Treatment intolerance including 1) The main organ function of the patient is evaluated by the doctor that can not be treated by the first-line standard;2) Patients received a first-line treatment with a 3/4 adverse reaction;3) Patients reject first-line treatment, etc)
Providing with tumor specimen (for testing the expression of PD -L1 and the infiltrating lymphocytes);
At least 1 measurable lesion (only 1 measurable lymph node lesion is excluded) (routine CT scan >=20mm, spiral CT scan >=10mm, no prior radiation to measurable lesions)

Key exclusion criteria (18 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
Prior antitumor therapy (including corticosteroids and immunotherapy) or participation in other clinical trials within past 4 weeks, or have not recovered from toxicities since the last treatment;
Pregnant or nursing;
Positive tests for HIV, HCV, HBsAg or HBcAb with positive test for HBV DNA (>500IU/ml);

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
humanized anti-PD-1 monoclonal antibody ToripalimabAlso: JS001, TAB001humanized anti-PD-1 monoclonal antibody Toripalimab is a programmed death-1 (PD-1) immune checkpoint inhibitor antibody, which selectively interferes with the combination of PD-1 with its ligands, PD-L1 and PD-L2, resulting in the activation of lymphocytes and elimination of malignancy theoretically.	Biological	humanized anti-PD-1monoclonal antibody

Primary outcome

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 3 years
Safety assessments including vital signs, laboratory tests, and adverse event monitoring

17 secondary outcomes

PD-1 receptor occupancy of blood
Time frame: 3 years
Objective Response Rate (ORR) by irRC and RECIST 1.1
Time frame: 3 years
Duration of Response (DOR) by irRC and RECIST 1.1
Time frame: 3 years
Disease Control Rate (DCR) by irRC and RECIST 1.1
Time frame: 3 years
Time to response (TTR) by irRC and RECIST 1.1
Time frame: 3 years
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
PK Parameter: Maximum Plasma Concentration (Cmax)
Time frame: 3 years
PK Parameter: Peak Time (Tmax)
Time frame: 3 years
PK Parameter: t1/2
Time frame: 3 years
PK Parameter: Area Under the Curve (AUC)
Time frame: 3 years
PK Parameter: Plasma clearance (CL)
Time frame: 3 years
PK Parameter: Apparent volume of distribution (V)
Time frame: 3 years
PK Parameter: Minimum Plasma Concentration (Cmin)
Time frame: 3 years
PK Parameter: Average Plasma Concentration (Cav)
Time frame: 3 years
PK Parameter: degree of fluctuation (DF)
Time frame: 3 years
PK Parameter: Apparent volume of distribution of steady state (Vss)
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 30 Sep 2020.
Background: 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.
Background: 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.
Derived from this study: PubMed 35193932Li S, Wu X, Yan X, Zhou L, Chi Z, Si L, Cui C, Tang B, Mao L, Lian B, Wang X, Bai X, Dai J, Kong Y, Tang X, Feng H, Yao S, Flaherty KT, Guo J, Sheng X. Toripalimab plus axitinib in patients with metastatic mucosal melanoma: 3-year survival update and biomarker analysis. J Immunother Cancer. 2022 Feb;10(2):e004036. doi: 10.1136/jitc-2021-004036.
Individual participant dataSharing planned: Yes

Related trials for Kidney Cancer Stage Iv

RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
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Active, not recruitingPhase 3
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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.

Jun Guo principal investigator

Peking University Cancer Hospital & Institute

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 12 inclusion and 18 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 30 Sep 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 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.

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?

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?

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 (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 NCT03086174, which also lists 3 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 30 Sep 2020.