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Renal Cell CarcinomaPhase 2NCT03827837

Famitinib Plus Anti-PD1 Therapy for Advanced Urinary System Tumor, Advanced Gynecological Tumors

A Phase 2 study testing SHR-1210 and Famitinib in people with Renal Cell Carcinoma and Urothelial Carcinoma, run by Jiangsu HengRui Medicine 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 The sponsor has not verified this record for over two years, so it may be out of date.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

Phase II multi-chort, adaptive two-stage, open label, nonrandomized study. The aim of our study is to evaluate the efficacy and safety of anti-PD-1 antibody SHR-1210(Camrelizumab) in combination with a small-molecule multikinase inhibitor Famitinib in subjects with advanced RCC/UC/CC/EC and recurrent OC. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
SHR-1210 and Famitinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
265 participants
Where
1 siteChina
Study dates
23 Jan 2019to Dec 2022
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Be willing and able to provide written informed consent/ for the trial.
  • Be at least 18 years of age on day of signing informed consent, male or female.
  • Patients with one of the following tumors:
  • Histologically or cytologically confirmed diagnosis of advanced renal cell carcinoma (defined as more than 50% clear cell component) after failure of IL-2 and/or anti-VEGF TKI treatment. If patients didn't want to use anti-VEGF TKI medicine or couldn't stand anti-VEGF TKI medicine costs, they will also be considered.
  • Histologically or cytologically confirmed diagnosis of unresectable urothelial carcinoma of the renal pelvis, ureter, bladder, or urethra (defined as more than 50% transitional cell component) after failure of no more than two prior platinum-based chemotherapeutic regimen.
  • Histologically or cytologically confirmed diagnosis of advanced squamous cell carcinoma of the cervix after failure of first-line system treatment.
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  • Histologically confirmed diagnosis of recurrent or refractory epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer that are relapsed and resistant (recurred less than 6 months after chemotherapy) or refractory (progressed on chemotherapy) to prior platinum-based standard care systemic regimen.
  • Histologically confirmed diagnosis of recurrent or refractory endometrial cancer that are relapsed and resistant or refractory (progressed on chemotherapy) to prior platinum-based standard care systemic regimen.
  • At least one measurable lesion according to RECIST 1.1.
  • The patients can swallow pills.
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.
  • Life expectancy of at least 12 weeks.
  • The results of patients' blood tests are as follows:-Neutrophils≥1.5E+9/L; - Plt≥90E+9/L; -Hb≥90g/L; -ALB≥30g/L ;-TSH≤1×ULN;-TBIL ≤ 1 ×ULN;-ALT and AST ≤ 3 ×ULN; AKP≤ 2.5×ULN; -Creatinine ≤ 1.5×ULN.
  • Male or Female patient of childbearing potential (entering the study after a menstrual period and who have a negative pregnancy test), who agrees to use two methods (one for the patient and one for the partner) of medically acceptable forms of contraception during the study and for 3 months after the last treatment intake.

Who cannot join

  • Patients with any active autoimmune disease or history of autoimmune disease, including but not limited to the following: hepatitis, pneumonitis, uveitis, colitis (inflammatory bowel disease), hypophysitis, vasculitis, nephritis, hyperthyroidism, and hypothyroidism, except for subjects with vitiligo or resolved childhood asthma/atopy. Asthma that requires intermittent use of bronchodilators or other medical intervention should also be excluded.
  • Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids. Doses > 10 mg/day prednisone or equivalent are prohibited within 2 weeks before study drug administration.
  • Known history of hypersensitivity to other antibody formulation.
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 2 weeks prior to trial treatment.
  • Hypertension and unable to be controlled within normal level following treatment of anti-hypertension agents: systolic blood pressure ≥140 mmHg, diastolic blood pressure ≥ 90 mmHg.
  • Clinically significant cardiovascular and cerebrovascular diseases, including but not limited to（1）Congestive heart failure (New York heart association (NYHA) class > 2)；（2）unstable or severe angina; （3）myocardial infarction within 12 months before enrollment；（4） ventricular arrhythmia which need medical intervention.（5）QTc>450ms（male）/QTc>470ms (female)；
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  • Coagulation abnormalities (INR>2.0、PT>16s), with bleeding tendency or are receiving thrombolytic or anticoagulant therapy.
  • Bleeding history, having bleeding event（≥3 Grade according CTCAE 4.0 ）within 4 weeks before screening.
  • Tumor invasion around major vessels shown by imaging, high risk of major vascular invasion leading to massive hemorrhage judged by investigators.
  • Previous Arterial/venous thrombosis events within 6 months.
  • Known hereditary or acquired bleeding and thrombosis tendency.
  • Proteinuria ≥ (++) and 24 hours total urine protein > 1.0 g.
  • Prior chemotherapy, radiotherapy, surgery therapy within 4 weeks or palliative radiotherapy within 2 weeks or target therapy within 5 half-life of the drug before the study drug administration, or any unresolved AEs > Common Terminology Criteria for Adverse Events (CTCAE) Grade 1.
  • Active infection or an unexplained fever > 38.5°C within 7 days before the study drug administration, or baseline WBC>15×E+9/L .
  • Has known history of Interstitial lung disease, or using steroids evidence of active, non-infectious pneumonitis, or would interfere with the detection and handling of suspicious drug-related pulmonary toxicity.
  • History of immunodeficiency or human immunodeficiency virus (HIV) infection.
  • HBV DNA>500 IU/ml，HCV RNA>1000copies/ml，HBsAg+ and anti-HCV+；
  • Has a known additional malignancy within the last 5 years, or that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer or patients with recurrent ovarian cancer has a known additional breast cancer that has been radical mastectomy and doesn't relapse within 3 years.
  • Patients with treatment history of SHR-1210 or any other PD-L1 or PD-1 antagonists or famitinib.
  • Patients who may receive live vaccine during the study, or previous had vaccination within 4 weeks.
  • Any other medical, psychiatric, or social condition deemed by the investigator to be likely to interfere with a subject's safety and participate in the study or would interfere with the interpretation of the results or lead to the trial being terminated early.

Trial locations and contacts

1 site in 1 country.

Quanren Wang, MD contact

(+86) 021-50118402

wangquanren@hrglobe.cn

China1 site, 1 recruiting

  • Huadong Hospital Affiliated to Fudan University

    Shanghai, Shanghai Municipality, 200136

    Director of urology

    Recruiting

Other trials in China

About this study

Official title: Famitinib Malate Plus Anti-PD1 Therapy (SHR-1210) in Advanced Renal Cell Carcinoma, Urothelial Carcinoma, Advanced Cervical Cancer, Relapse Ovarian Cancer, Endometrial Cancer: Multi-institutional, Open-label, Phase 2 Trial

Phase II multi-chort, adaptive two-stage, open label, nonrandomized study. The aim of our study is to evaluate the efficacy and safety of anti-PD-1 antibody SHR-1210(Camrelizumab) in combination with a small-molecule multikinase inhibitor Famitinib in subjects with advanced RCC/UC/CC/EC and recurrent OC.

chort1: Renal Cell Carcinoma (RCC) chort2: Urothelial Carcinoma(UC) chort3: Ovarian Cancer (OC) chort4: Cervical Cancer (CC) chort5: Endometrial Cancer (EC)

Read the detailed description

Stage 1: Approximately 110 participants will be recruited, 22 participants per chort; Stage 2: Approximately 55 participants will be recruited, 11 participants per chort, if more than 7（including 7） patients reached ORR in every chort ; Approximately 155 participants will be recruited, 21 participants per chort, if 3 ≤ patients <7 patients reached ORR in every chort.

Being tested
SHR-1210, Famitinib
Medical subject headings
Carcinoma, Renal Cell, Carcinoma, Transitional Cell, Uterine Cervical Neoplasms, Endometrial Neoplasms

What participants receive

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

  • SHR-1210Biological

    Also called Camrelizumab

    SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody

  • FamitinibDrug

    Also called Famitinib Malate Capsule

    a small-molecule multikinase inhibitor

Study groups in NCT03827837
Study groupRoleWhat they receive
SHR-1210 combined with FamitinbExperimentalSHR-1210 + Famitinib
Receives: Biological: SHR-1210; Drug: Famitinib

What is being measured

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

  1. Overall response rate (ORR)

    Defined as complete or partial response per RECIST 1.1 criteria with assessment every 9 weeks

    Measured: Up to 2 years

Secondary outcomes (12)

  1. Duration of Response (DoR)

    Duration of Response (DoR) per RECIST 1.1

    Measured: Up to 2 years

  2. Disease Control Rate (DCR)

    Disease Control Rate per RECIST 1.1

    Measured: Up to 2 years

  3. Time to objective response(TTR)

    Time to objective response per RECIST 1.1

    Measured: Up to 2 years

  4. Progression-free survival(PFS)

    Progression-free survival(PFS) per RECIST 1.1

    Measured: Up to 2 years

  5. Overall survival(OS)

    Overal Survial will be calculated based on Kaplan-Meier estimates

    Measured: Up to 2 years

  6. 12-month survival rate

    12-month survival rate will be calculated based on Kaplan-Meier estimates of Overall survival at 12 months

    Measured: Up to 1 year

  7. number of participants who experience an adverse event (AE)

    number of participants who experience an adverse event (AE) per CTCAE 4.03

    Measured: From the first assignment of informed consent form up to 90 days after the last dose

  8. serum SHR-1210 concentrations

    serum SHR-1210 concentrations

    Measured: From the first dose up to 30 days after the last dose

  9. Positive rate of ADA

    Positive rate of anti-SHR1210 antibody

    Measured: From the first dose up to 30 days after the last dose

  10. Maximum Observed Plasma Concentration (Cmax)

    Cmax, based PK parameters

    Measured: Day 1 of cycle 3 (each cycle is 21 days)

  11. Time to Reach Maximum Observed Plasma Concentration (Tmax)

    Summarized by dose, cycle, day and time

    Measured: Day 1 of cycle 3 (each cycle is 21 days)

  12. Apparent Oral Clearance (CL/F)

    Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.

    Measured: Day 1 of cycle 3 (each cycle is 21 days)

Timeline

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

  1. First posted4 Feb 2019
  2. Study start23 Jan 2019
  3. Primary completionDec 2022 (estimated)
  4. Study completionDec 2022 (estimated)

Resources

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
Masking
None (open label)
Enrolment
265 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03827837
Sponsor's protocol ID
SHR-1210-II-213
Status last verified
Jun 2022
First submitted
12 Nov 2018
Last updated
1 Jul 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Xia L, Zhou Q, Gao Y, Hu W, Lou G, Sun H, Zhu J, Shu J, Zhou X, Sun R, Wu X. A multicenter phase 2 trial of camrelizumab plus famitinib for women with recurrent or metastatic cervical squamous cell carcinoma. Nat Commun. 2022 Dec 8;13(1):7581. doi: 10.1038/s41467-022-35133-4.

    PubMed 36481736

  • Qu YY, Sun Z, Han W, Zou Q, Xing N, Luo H, Zhang X, He C, Bian XJ, Cai J, Chen C, Wang Q, Ye DW. Camrelizumab plus famitinib for advanced or metastatic urothelial carcinoma after platinum-based therapy: data from a multicohort phase 2 study. J Immunother Cancer. 2022 May;10(5):e004427. doi: 10.1136/jitc-2021-004427.

    PubMed 35537782

  • Xia L, Peng J, Lou G, Pan M, Zhou Q, Hu W, Shi H, Wang L, Gao Y, Zhu J, Zhang Y, Sun R, Zhou X, Wang Q, Wu X. Antitumor activity and safety of camrelizumab plus famitinib in patients with platinum-resistant recurrent ovarian cancer: results from an open-label, multicenter phase 2 basket study. J Immunother Cancer. 2022 Jan;10(1):e003831. doi: 10.1136/jitc-2021-003831.

    PubMed 35017154

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SHR-1210 and Famitinib in people with Renal Cell Carcinoma and Urothelial Carcinoma, run by Jiangsu HengRui Medicine Co., Ltd. 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 14 inclusion and 21 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 1 Jul 2022. 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 Quanren Wang, MD ((+86) 021-50118402, wangquanren@hrglobe.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response rate (ORR) (time frame: Up to 2 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 NCT03827837, 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 1 Jul 2022.

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