Famitinib Plus Anti-PD1 Therapy for Advanced Urinary System Tumor, Advanced Gynecological Tumors
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ClinicalTrials.gov Identifier: NCT03827837 |
Recruitment Status :
Recruiting
First Posted : February 4, 2019
Last Update Posted : July 1, 2022
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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)
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Renal Cell Carcinoma Urothelial Carcinoma Cervical Cancer Ovarian Cancer Recurrent Endometrial Cancer | Biological: SHR-1210 Drug: Famitinib | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 265 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | January 23, 2019 |
Estimated Primary Completion Date : | December 2022 |
Estimated Study Completion Date : | December 2022 |
Arm | Intervention/treatment |
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Experimental: SHR-1210 combined with Famitinb
SHR-1210 + Famitinib
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Biological: SHR-1210
SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody
Other Name: Camrelizumab Drug: Famitinib a small-molecule multikinase inhibitor
Other Name: Famitinib Malate Capsule |
- Overall response rate (ORR) [ Time Frame: Up to 2 years ]Defined as complete or partial response per RECIST 1.1 criteria with assessment every 9 weeks
- Duration of Response (DoR) [ Time Frame: Up to 2 years ]Duration of Response (DoR) per RECIST 1.1
- Disease Control Rate (DCR) [ Time Frame: Up to 2 years ]Disease Control Rate per RECIST 1.1
- Time to objective response(TTR) [ Time Frame: Up to 2 years ]Time to objective response per RECIST 1.1
- Progression-free survival(PFS) [ Time Frame: Up to 2 years ]Progression-free survival(PFS) per RECIST 1.1
- Overall survival(OS) [ Time Frame: Up to 2 years ]Overal Survial will be calculated based on Kaplan-Meier estimates
- 12-month survival rate [ Time Frame: Up to 1 year ]12-month survival rate will be calculated based on Kaplan-Meier estimates of Overall survival at 12 months
- number of participants who experience an adverse event (AE) [ Time Frame: From the first assignment of informed consent form up to 90 days after the last dose ]number of participants who experience an adverse event (AE) per CTCAE 4.03
- serum SHR-1210 concentrations [ Time Frame: From the first dose up to 30 days after the last dose ]serum SHR-1210 concentrations
- Positive rate of ADA [ Time Frame: From the first dose up to 30 days after the last dose ]Positive rate of anti-SHR1210 antibody
- Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Day 1 of cycle 3 (each cycle is 21 days) ]Cmax, based PK parameters
- Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: Day 1 of cycle 3 (each cycle is 21 days) ]Summarized by dose, cycle, day and time
- Apparent Oral Clearance (CL/F) [ Time Frame: Day 1 of cycle 3 (each cycle is 21 days) ]Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
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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.
- 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.
Exclusion Criteria:
- 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);
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03827837
Contact: Quanren Wang, MD | (+86) 021-50118402 | wangquanren@hrglobe.cn |
China, Shanghai | |
Huadong Hospital Affiliated to Fudan University | Recruiting |
Shanghai, Shanghai, China, 200136 | |
Contact: Director of urology |
Principal Investigator: | Dingwei Ye, MD | Fudan University | |
Principal Investigator: | Xiaohua Wu, MD | Fudan University |
Responsible Party: | Jiangsu HengRui Medicine Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT03827837 |
Other Study ID Numbers: |
SHR-1210-II-213 |
First Posted: | February 4, 2019 Key Record Dates |
Last Update Posted: | July 1, 2022 |
Last Verified: | June 2022 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Carcinoma Ovarian Neoplasms Carcinoma, Ovarian Epithelial Uterine Cervical Neoplasms Carcinoma, Renal Cell Endometrial Neoplasms Carcinoma, Transitional Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Ovarian Diseases Adnexal Diseases Genital Diseases, Female |
Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Genital Neoplasms, Female Urogenital Neoplasms Genital Diseases Endocrine System Diseases Gonadal Disorders Uterine Neoplasms Uterine Cervical Diseases Uterine Diseases Adenocarcinoma Kidney Neoplasms Urologic Neoplasms Kidney Diseases |