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

NCT03827837 | Unknown Phase 2

• 1 other identifier: SHR-1210-II-213
• Study Type: interventional
• Target: 265
• Locations: 1 country
• Sites: 1

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

Conditions

Renal Cell Carcinoma; Urothelial Carcinoma; Cervical Cancer; Ovarian Cancer Recurrent; Endometrial Cancer

Outcome Measures

Primary Outcomes (1)

• Overall response rate (ORR)

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

  Up to 2 years

Secondary Outcomes (12)

• Duration of Response (DoR)

  Up to 2 years

• Disease Control Rate (DCR)

  Up to 2 years

• Time to objective response(TTR)

  Up to 2 years

• Progression-free survival(PFS)

  Up to 2 years

• Overall survival(OS)

  Up to 2 years

Study Arms (1)

SHR-1210 combined with Famitinb

EXPERIMENTAL

SHR-1210 + Famitinib

Biological: SHR-1210; Drug: Famitinib

Interventions

SHR-1210 BIOLOGICAL

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

Also known as: Camrelizumab

SHR-1210 combined with Famitinb

Famitinib DRUG

a small-molecule multikinase inhibitor

Also known as: Famitinib Malate Capsule

SHR-1210 combined with Famitinb

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Huadong Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, 200136, China

RECRUITING

Related Publications (3)

• 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.

  PMID: 36481736 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.

  PMID: 35537782 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.

  PMID: 35017154 DERIVED

MeSH Terms

Conditions

Carcinoma, Renal Cell; Carcinoma, Transitional Cell; Uterine Cervical Neoplasms; Endometrial Neoplasms

Interventions

camrelizumab; famitinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Genital Diseases

Study Officials

• Dingwei Ye, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

• Xiaohua Wu, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Quanren Wang, MD

CONTACT

(+86) 021-50118402; wangquanren@hrglobe.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2018
• First Posted: February 4, 2019
• Study Start: January 23, 2019
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: July 1, 2022

Record last verified: 2022-06

Locations

CN (1)