A Phase II Clinical Trial of Cediranib and Olaparib Maintenance in Advanced Recurrent Cervical Cancer

NCT04487587 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: CCC844
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

COMICE is a randomised, double blind placebo controlled Phase II trial. The trial is recruiting 108 patients with advanced recurrent cervical cancer who have completed their 1st line chemotherapy for advanced/recurrent disease. Patients will be randomised to either placebo Cediranib and Olaparib or active Cediranib and Olaparib and will remain on treatment until progression of disease, unacceptable toxicity or withdrawal of consent. Patients will be assessed for disease progression every 8 weeks through CT/MRI imaging. The primary end point is Progression Free Survival.

Conditions

Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  Date of disease progression \*Current standard of care in this group of patients would be clinical follow up with no treatment

  The study ends when the last patient recruited has completed a minimum of 7 months on study. Recruitment period is 14 months so the maximum time a patient will be on study for is 21 months

Secondary Outcomes (4)

• Rate of Toxicity

  SAEs are reported from randomisation to 30 days following the last administration of study IMP

• Quality of Life FACT-Cx

  completed at baseline then at the four weekly treatment review visit, up to the earlier of disease progression or 7 months

• Overall Survival

  from randomisation until date of death from any cause, assessed up to 21 months

• Tumour Response

  from date of randomisation until the date of first documented disease progression, assessed up to 21 months

Study Arms (2)

Active

ACTIVE COMPARATOR

Cediranib 20mg tablet OD (5 days out of 7) and Olaparib 300mg tablet BD (continuous) + standard of care

Drug: Cediranib, Olaparib

Placebo

PLACEBO COMPARATOR

Placebo Cediranib 20mg tablet OD (5 days out of 7) and Placebo Olaparib 300mg tablet BD (continuous) + standard of care

Drug: Cediranib, Olaparib

Interventions

Cediranib, Olaparib DRUG

Cediranib film coated tablet, Olaparib film coated tablet

Active; Placebo

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: patients are eligible if diagnosed with cervical cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over 18 years of age
• Histologically proven carcinoma of the cervix (squamous, adenocarcinoma or mixed adeno/squamous).
• Completion of first line platinum-based chemotherapy for advanced /recurrent disease, leading to either a complete response, partial response or stable disease.
• ECOG performance status 0 or 1
• Randomisation within 8 weeks of completion of chemotherapy
• Patients may have received previous chemoradiotherapy and neoadjuvant chemotherapy given with a curative intent.
• Creatinine Clearance ≥ 51mls/min
• Adequate haematological and biochemical function, as follows:
• Haemoglobin \> 10g/dl (with no blood transfusion in the 28 days prior to randomisation) Neutrophils \> 1.5 x 109/l
• Platelets \> 100 x 109/l
• Bilirubin \< 1.5 x ULN
• ALT or AST/ SGOT \< 3 x ULN (or ≤5 x ULN if hepatic metastases present)
• Alkaline Phosphatase \< 3 x ULN (or ≤5 x ULN if hepatic metastases present)
• Adequate coagulation, as follows:
• Prothrombin ratio (PTR) / INR ≤ 1.5 or

You may not qualify if:

• Disease that is potentially treatable with exenterative surgery.
• Relapse confined to the pelvis after radical surgery in circumstance where radiotherapy or chemoradiotherapy would be appropriate.
• More than one line of prior chemotherapy for advanced/recurrent disease. Neoadjuvant chemotherapy is not counted.
• Prior treatment with anti-angiogenic agents (with the exception of bevacizumab given as part of first line chemotherapy)
• History of other malignancy within the previous 5 years except for:
• Curatively treated basal cell or squamous cell carcinoma of skin; in situ cancer of the cervix, ductal carcinoma in situ of the breast or stage 1, grade 1 endometrial carcinoma.
• Curatively treated other solid tumors including lymphomas (without bone marrow involvement) with no evidence of disease for ≥5 years prior to start of IMPs.
• Pregnant or lactating women.
• Fertile woman of childbearing potential not willing to use adequate contraception (oral contraceptives, intrauterine device or barrier method of contraception in conjunction with spermicidal jelly or surgically sterile) for the study duration and at least six months afterwards
• Evidence of uncontrolled infection. (Defined as infection that cannot be resolved readily with antibiotics prior to patient entry into the trial for example a pelvic collection)
• History of pelvic fistulae.
• History of abdominal fistula that has been surgically corrected within 6 months of starting treatment. Patient should be deemed low risk of recurrent fistula
• Sub-acute or acute intestinal obstruction.
• Major surgery within 28 days or anticipated while on study.
• Non-healing wound, ulcer or bone fracture.

Sponsors & Collaborators

• The Clatterbridge Cancer Centre NHS Foundation Trust: lead
• University of Liverpool: collaborator

Study Sites (1)

Clatterbridge Cancer Centre

Metropolitan Borough of Wirral, CH63 4JY, United Kingdom

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

cediranib; olaparib

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: COMICE is a double blind trial, the Investigator, Patient, Hospital Staff, Pharmacy and the COMICE trial team (Chief Investigator, Monitor, Trial Coordinator) are blinded to the treatment allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients are randomised 1:1 to either placebo Cediranib and Olaparib or active Cediranib and Olaparib

Study Record Dates

• First Submitted: February 12, 2020
• First Posted: July 27, 2020
• Study Start: October 9, 2018
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2026
• Last Updated: February 26, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)