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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)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-1210 combined with Famitinb | Experimental | SHR-1210 + Famitinib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1210 | Biological | SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (ORR) | Defined as complete or partial response per RECIST 1.1 criteria with assessment every 9 weeks | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response (DoR) | Duration of Response (DoR) per RECIST 1.1 | Up to 2 years |
| Disease Control Rate (DCR) | Disease Control Rate per RECIST 1.1 |
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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.
Patients with one of the following tumors:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Quanren Wang, MD | Contact | (+86) 021-50118402 | wangquanren@hrglobe.cn |
| Name | Affiliation | Role |
|---|---|---|
| Dingwei Ye, MD | Fudan University | Principal Investigator |
| Xiaohua Wu, MD | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huadong Hospital Affiliated to Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200136 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36481736 | Derived | 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. | |
| 35537782 | Derived | 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. |
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| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| D002295 | Carcinoma, Transitional Cell |
| D002583 | Uterine Cervical Neoplasms |
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C000631724 | camrelizumab |
| C584390 | famitinib |
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| Famitinib | Drug | a small-molecule multikinase inhibitor |
|
|
| Up to 2 years |
| Time to objective response(TTR) | Time to objective response per RECIST 1.1 | Up to 2 years |
| Progression-free survival(PFS) | Progression-free survival(PFS) per RECIST 1.1 | Up to 2 years |
| Overall survival(OS) | Overal Survial will be calculated based on Kaplan-Meier estimates | Up to 2 years |
| 12-month survival rate | 12-month survival rate will be calculated based on Kaplan-Meier estimates of Overall survival at 12 months | Up to 1 year |
| number of participants who experience an adverse event (AE) | number of participants who experience an adverse event (AE) per CTCAE 4.03 | From the first assignment of informed consent form up to 90 days after the last dose |
| serum SHR-1210 concentrations | serum SHR-1210 concentrations | From the first dose up to 30 days after the last dose |
| Positive rate of ADA | Positive rate of anti-SHR1210 antibody | From the first dose up to 30 days after the last dose |
| Maximum Observed Plasma Concentration (Cmax) | Cmax, based PK parameters | Day 1 of cycle 3 (each cycle is 21 days) |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) | Summarized by dose, cycle, day and time | Day 1 of cycle 3 (each cycle is 21 days) |
| 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. | Day 1 of cycle 3 (each cycle is 21 days) |
| 35017154 | Derived | 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. |
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D000091662 | Genital Diseases |