NCT05234905

H101 Combined With Camrelizumab for Recurrent Cervical Cancer

Oncolytic Virus(H101) Combined With Camrelizumab for Recurrent Cervical Cancer: a Prospective, Multicenter Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (estimated)
• Sponsor: Zhejiang Cancer Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

There is no standard treatment for recurrent cervical cancer that progresses or persists after first-line treatment. The objective response rate of anti-PD-1 antibody treatment is about 15%. The purpose of this study was to evaluate whether the regimen could improve the objective response rate by intratumoral injection of oncolytic virus(recombinant human adenovirus type 5 injection, H101) combined with anti-PD-1 antibody(camrelizumab).

Detailed description

1. Main research purpose To evaluate the efficacy of H101 combined with camrelizumab in patients with incurable recurrent cervical cancer. 2. Secondary research purpose To evaluate other curative effects of H101 combined with camrelizumab in patients with incurable recurrent cervical cancer. To evaluate the safety of H101 combined with camrelizumab in patients with incurable recurrent cervical cancer. 3. Purpose of Exploratory Research To explore the changes of tumor microenvironment before and after H101 injection and the mechanism of action in combination with PD-1, and to accurately screen the beneficiaries based on molecular expression. 4. Overall experimental design This study is a multicenter, prospective, clinical study to investigate the efficacy and safety of H101 combined with camrelizumab in the treatment of incurable recurrent cervical cancer patients. It is expected that 55 subjects will be enrolled. The study was divided into 5 phases: screening period, baseline period, treatment period, and follow-up period. Patients with recurrent cervical cancer who were eligible for inclusion and were incurable by previous first-line treatment were screened. During the follow-up period, follow-up was conducted every 1 month for at least 2 years. 5. Subject population The target population of this study was patients with recurrent cervical squamous cell carcinoma/adenocarcinoma/adenosquamous carcinoma who were incurable after first-line therapy. 6. Treatment allocation All subjects enrolled in this study received H101 combined with camrelizumab. 7. Drug dosage and administration in the trial Dosing regimen: H101 + camrelizumab. 1) H101: 1 lesion was selected for intratumoral injection. Intratumoral injection of H101 was used on the 1st and 4th day of each cycle, repeated once in 3 weeks. H101 dosage: Tumor maximum diameter ≤5 cm, 1.5×10\^12vp (3 injections) on day 1 and 1.0×10\^12vp (2 injections) on day 4. Tumor maximum diameter \>5cm but ≤10cm, 3.0×10\^12vp (6 injections) on day 1, 2.0×10\^12vp (4 injections) on day 4. Tumor maximum diameter \>10cm, 4.5×10\^12vp (9 injections) on day 1 and 3.0×10\^12vp (6 injections) on day 4. H101 will be used until injected lesion disappears or 5 cycles, whichever occurs first. 2\) Camrelizumab: 200 mg intravenously. Dosing after H101 on day 1 of each cycle, repeated 3 weeks. The drug was discontinued or discontinued for 2 years until the patient developed tumor progression or intolerable toxicity.

Conditions

• Uterine Cervical Neoplasms
• Oncolytic Virotherapy
• Camrelizumab

Interventions

Type	Name	Description
DRUG	Recombinant human adenovirus type 5＋Camrelizumab	Recombinant human adenovirus type 5: one lesion was selected for intratumoral injection.Intratumoral injection of H101 was performed on day 1 and day 4 of each cycle, and was repeated once every 3 weeks. H101 dose: ① Tumor maximum diameter ≤5cm, 1.5×1012vp (3 injections) on day 1, 1.0×1012vp (2 injections) on day 4. ② Tumor maximum diameter \>5cm but ≤10cm, 3.0×1012vp (6 injections) on day 1 and 2.0×1012vp (4 injections) on day 4. ③ Tumor maximum diameter \>10cm, 4.5×1012vp (9 injections) on day 1 and 3.0×1012vp (6 injections) on day 4. H101 intratumoral injection until the tumor is completely regressed to stop the drug, but not more than 5 cycles at most. Camrelizumab: administered after H101 on day 1 of each cycle and repeated for 3 weeks. Camrelizumab dose: 200 mg IV.

Timeline

• Start date: 2022-03-01
• Primary completion: 2023-06-01
• Completion: 2024-12-01
• First posted: 2022-02-10
• Last updated: 2022-02-10

Locations

4 sites across 1 country: China