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Special Combination of OBP-301 and Pembrolizumab

NCT03172819 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2022-09-28

No results posted yet for this study

Summary

This is multicenter, open-label Phase I study to exploratively evaluate the efficacy and safety of OBP-301 in combination with Pembrolizumab in patients with advanced solid tumors.

Conditions

  • Advanced Solid Tumor

Interventions

BIOLOGICAL

OBP-301

Intratumoral injection directly into the dose target region of a tumor at Day 1, Day 15, and Day 29. Additional administration of OBP-301 After the recommended dose of OBP-301 has been established, additional administration of OBP-301 is allowed. After completion of administration of OBP-301 on Day 1 - Day 29(+/- 4 days), if the target region has not disappeared, additional administration of OBP-301 is allowed after Day 43 or later. The patients in Phase 1a, Pembrolizumab administration has continued, are included. The recommended dose determined in the Phase 1a part will be administered 3 times biweekly (+/- 4 days); max 4 cycles.

DRUG

Pembrolizumab

200 mg Pembrolizumab is infused intravenously at Day 8. Thereafter infusion will continue every 3 weeks until discontinuation.

Sponsors & Collaborators

  • Oncolys BioPharma Inc

    collaborator INDUSTRY

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • Toshihiko Doi

    lead OTHER

Principal Investigators

  • Toshihiko Doi, Dr · National Cancer Center Hospital East

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-01
Primary Completion
2021-04-06
Completion
2022-04-06

Countries

  • Japan

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03172819 on ClinicalTrials.gov