Durvalumab and Lenvatinib in Participants With Advanced and Recurrent Endometrial Carcinoma

NCT04444193 | Unknown

• 1 other identifier: SHFMIH-IIT-2020-0005
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will evaluate the safety and efficacy of durvalumab in combination with lenvatinib in participants with advanced and recurrent endometrial carcinoma.The primary hypothesis of this study are that patients with advanced and recurrent endometrial carcinoma could benefit from durvalumab plus lenvatinib with respect to: 1)Progression Free Survival (PFS) ; 2) Objective Response Rate (ORR); and Overall survival (OS). The investigators design a clinical study to explore whether the combination above as a treatment in patients with advanced and recurrent endometrial carcinoma could prolong PFS and to analyze potential immune biomarker of therapeutic response.

Conditions

Endometrial Cancer

Keywords

endometrial cancer

Outcome Measures

Primary Outcomes (2)

• Progression Free Survival (PFS)

  Defined as time from randomisation to first progression by investigator assessment using modified RECIST 1.1 or death (by any cause in the absence of progression)

  Up to 3 years

• Objective Response Rate (ORR)

  Objective response rate is defined as the proportion of patients with measurable disease at baseline who have confirmed complete response (CR) or partial response (PR) as determined by the Investigator at local site

  Up to 3 years

Secondary Outcomes (2)

• Overall Survival (OS)

  Up to 5 years

• Percentage of Participants who Experience an Adverse Event (AE)

  Up to 1 years

Study Arms (1)

Durvalumab and Lenvatinib

EXPERIMENTAL

Combination therapy of Lenvatinib 80-120mg daily orally and durvalumab 1500mg by IV infusion every 4 weeks

Drug: Durvalumab; Drug: Lenvatinib Oral Product

Interventions

Durvalumab DRUG

Anti-PD-L1 Monoclonal Antibody

Also known as: Durvalumab injection

Durvalumab and Lenvatinib

Lenvatinib Oral Product DRUG

Lenvatinib (Lenvima, Eisai China) is a novel angiogenesis inhibitor which targets vascular endothelial growth factor 1-3, fibroblast growth factor receptor 1-4, platelet-derived growth factor receptor β, RET and KIT

Also known as: LENVIMA

Durvalumab and Lenvatinib

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years at the time of screening and female.
• Histologically confirmed diagnosis of epithelial endometrial carcinoma.
• Patient must have endometrial cancer in one of the following categories:
• Newly diagnosed Stage III disease (measurable disease per RECIST 1.1 following surgery or diagnostic biopsy),
• Newly diagnosed Stage IV disease (with or without disease following surgery or diagnostic biopsy)
• Recurrence of disease where the potential for cure by surgery alone or in combination is poor.
• Not eligible for hormonal therapy (because of negative hormone receptor/poor differentiation, or after failure of hormonal therapy).
• Naïve to first line systemic anti-cancer treatment. For patients with recurrent disease only, prior chemotherapy is allowed only if it was administered in the adjuvant setting and there is at least 12 months from date of last dose of chemotherapy administered to date of subsequent relapse
• Adequate organ system function as measured within 28 days prior to administration of study treatment, as defined below:
• Haemoglobin ≥ 10.0 g/dL, with no blood transfusion in the past 28 days. Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L Platelet count ≥ 100 x 10\^9/L Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (not applicable to Gilbert's syndrome) Aspartate aminotransferase (AST) (Serum Glutamic Oxaloacetic Transaminase (SGOT)) / Alanine aminotransferase (ALT) (Serum Glutamic Pyruvate Transaminase (SGPT)) ≤ 2.5 x ULN unless liver metastases are present in which case they must be ≤ 5x ULN Patients must have creatinine clearance estimated of ≥51 mL/min estimated using the Cockcroft-Gault equation or 24 hr urine clearance.

You may not qualify if:

• Any previous treatment with a PD1 or PD-L1 inhibitor
• Has a history of (noninfectious) pneumonitis that required steroids or has current pneumonitis
• History of leptomeningeal carcinomatosis, symptomatic uncontrolled brain metastases (≤2mg/ day corticosteroids started ≥4 weeks prior to treatment is accepted) and spinal cord compression (unless received definitive treatment and clinically stable for 28 days) .
• Has an active infection requiring systemic therapy.
• Has a known history of human immunodeficiency virus (HIV) infection.
• Has known active tuberculosis (TB; Bacillus tuberculosis).
• Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137).
• Has received a live vaccine within 30 days prior to the first dose of study treatment.
• Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to Cycle 1, Day 1.
• Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to Cycle 1, Day 1.
• Has severe hypersensitivity (≥Grade 3) to Durvalumab and/or any of its excipients.
• Has an active autoimmune disease that has required systemic treatment in past 2 years.
• Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.
• Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment.

Sponsors & Collaborators

• Shanghai First Maternity and Infant Hospital: lead

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

durvalumab; lenvatinib

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Xiaoping Wan, MD.,Ph.D

  Shanghai First Maternity and Infant Hospital

  STUDY CHAIR

• Huan Tong

  Shanghai First Maternity and Infant Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huan Tong

CONTACT

008615216653806; tonghuan@tongji.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2020
• First Posted: June 23, 2020
• Study Start: August 31, 2020
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2021
• Last Updated: June 23, 2020

Record last verified: 2020-06