A phase Ib study of Durvalumab (MEDI4736) in combination with carbon-ion radiotherapy and weekly cisplatin for patients with locally advanced cervical cancer

Phase 1

• Conditions: cervical cancer; D002583

• Registration Number: JPRN-jRCT2031210083
• Lead Sponsor: Murata Kazutoshi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-12
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 10

Inclusion Criteria

1. Age >= 20 years and <= 75 years for Japanese patients.
2. Histologically proven uterine cervical cancer; Stage IIB, IIIA, IIIB, IIIC1, and IVA in FIGO 2018 staging.
3. Tumor assessment by computed tomography scan or magnetic resonance imaging must be performed within 28 days prior to.
4. No prior chemotherapy, radiotherapy, or immunotherapy for cervical cancer.
5. ECOG performance status of 0 or 1.
6. Body weight > 30 kg
7. Adequate normal organ and marrow function as defined below:
Haemoglobin >= 9.0 g/dL
Absolute neutrophil count >= 1000 per mm3
Platelet count >= 75 x 109/L
Serum bilirubin <= 1.5 x institutional upper limit of normal.
8. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
9. Must have a life expectancy of at least 12 weeks.
10. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol.

Exclusion Criteria

1) Participation in another clinical study with an investigational product during the last 3 months.
2) Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.
3) Receipt of the last dose of anticancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies) for other previous or concomitant tumor within 1 years prior to the first dose of study drug.
4) Any unresolved toxicity NCI CTCAE Grade >=2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria.
a. Patients with Grade <= 2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician.
b. Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the Study Physician.
5) Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.
6) Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug
7) Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable.
8) History of allogenic organ transplantation.
9) Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). The following are exceptions to this criterion:
a. Patients with vitiligo or alopecia
b. Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement
c. Any chronic skin condition that does not require systemic therapy
d. Patients without active disease in the last 5 years may be included but only after consultation with the study physician
e. Patients with celiac disease controlled by diet alone
10) Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent
11) History of another primary malignancy except for
a. Malignancy treated with curative intent and with no known active disease >=5 years before the first dose of IP and of low potential risk for recurrence
b. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
c. Adequately treated carcinoma in situ without evidence of disease
12) History of leptomeningeal carcinomatosis
13) History of active primary immunodeficiency
14) Active infection including tuberculosis (clinical evaluation that includes clinical histor

Study & Design

• Study Type: Interventional
• Study Design: Not specified