A Study of Sintilimab in Combination With Axitinib in Advanced Renal Cell Cancer

NCT04958473 | Unknown Phase 2 DMC

• 1 other identifier: SAARCC
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

In patients with recurrent or metastatic renal cell carcinoma, a preliminary evaluation of the safety and efficacy of sintilimab combined with axitinib in patients with advanced renal cell carcinoma was conducted.Progression-free survival (PFS), overall survival (OS), disease control rate (DCR) and disease remission rate (ORR) were evaluated.

Conditions

Renal Cell Carcinoma; Clear Cell Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Overall response rate (ORR)

  To be assessed by RECIST 1.1

  Up to 12 months

Secondary Outcomes (4)

• Progression free survival (PFS)

  From randomization up to 3 years.

• Overall Survival (OS)

  Every 3 months up to 3 years.

• Disease Control Rate (DCR)

  Every 6 weeks up to 18 months from patient enrollment in the study, then every 12 weeks up to 3 years from randomization

• Incidence of treatment-related adverse events

  Up to 3 years.

Study Arms (1)

Patients with advanced RCC

EXPERIMENTAL

Patients with a diagnosis of kidney cancer (renal cell carcinoma, advanced or metastatic, previously treated or untreated)

Drug: Sintilimab; Drug: Axitinib

Interventions

Sintilimab DRUG

PD-1 inhibitor，Sintilimab 200mg IV, every 3 weeks.

Also known as: Tyvyt, IBI 308

Patients with advanced RCC

Axitinib DRUG

Tyrosine kinase inhibitor，licensed for use in treatment of renal cell carcinoma. Oral treatment Axitinib given 5 mg PO BID.

Also known as: Inlyta

Patients with advanced RCC

Eligibility Criteria

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

You may qualify if:

• Signed written informed consent before performance of study-specific procedures or assessments and must be willing to comply with treatment and follow up
• Diagnosis of locally advanced or metastatic RCC that is predominantly clear cell histology
• Must have measurable disease
• Subject has received no prior systemic therapy
• A woman is eligible to participate in the study if she is of Non-childbearing potential, has a negative serum pregnancy test within 7 days of the first dose of study treatment, not lactating, and agrees to use adequate contraception during the study until at least 120 days after the last dose of investigational product
• Eastern Cooperative Oncology Group performance status 0 or 1
• Adequate organ function as defined in the protocol
• Left ventricular ejection fraction \>= lower limit of normal as assessed by echocardiogram or multigated acquisition scan

You may not qualify if:

• Subject has an active autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents
• Subject is currently participating or has participated in a study of an investigational agent or using an investigational device within 30 days of the first dose of study treatment
• Subject is expected to require any other form of systemic or localized antineoplastic therapy while on study
• Subject is on any systemic steroid therapy, within one week before the planned date for first dose of study treatment. Subject is on any other form of immunosuppressive medication
• Unable to swallow and retain orally administered medication
• Active peptic ulcer disease, inflammatory bowel disease, ulcerative colitis, or other -Gastrointestinal conditions with increased risk of perforation; history of abdominal fistula, GI perforation, or intra-abdominal abscess within 4 weeks before beginning study treatment
• Known history of HIV infection or a known history of or is positive for Hepatitis B or Hepatitis C
• Presence of active infection requiring systemic therapy
• Corrected QT interval duration prolongation
• History of any one or more of the following cardiac conditions within the past 6 months: Cardiac angioplasty or stenting; Myocardial infarction; Unstable angina; ----History of Class III or IV congestive heart failure according to New York Heart Association classification
• History of cerebrovascular accident within the past 6 months
• Poorly controlled hypertension
• History of untreated deep venous thrombosis
• Presence of any non-healing wound, fracture, or ulcer, or presence of symptomatic peripheral vascular disease
• Evidence of bleeding diathesis or coagulopathy

Sponsors & Collaborators

• Tianjin Medical University Second Hospital: lead

Study Sites (1)

Tianjin Medical Unversity Second Hospital

Tianjin, Tianjin Municipality, 300211, China

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

sintilimab; Axitinib

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

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• BIN HUO, MD

  Tianjin Medical University Second Hospital

  PRINCIPAL INVESTIGATOR

• Haitao Wang, PhD

  Tianjin Medical University Second Hospital

  STUDY DIRECTOR

Central Study Contacts

BIN HUO, MD

CONTACT

+86 22 88326610; huobin_doctor@icloud.com

Study Design

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

Study Record Dates

• First Submitted: June 23, 2021
• First Posted: July 12, 2021
• Study Start: August 1, 2021
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2025
• Last Updated: July 12, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)