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Clinical Trial of SBRT and Systemic Pembrolizumab With or Without Avelumab/Ipilimumab+ Dendritic Cells in Solid Tumors

NCT04571632 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2022-09-14

No results posted yet for this study

Summary

A randomized phase II clinical trial of SBRT and systemic pembrolizumab with or without intratumoral avelumab/ipilimumab plus CD1c (BDCA-1)+/CD141 (BDCA-3)+ myeloid dendritic cells in solid tumors.

Conditions

Interventions

DRUG

Avelumab

Avelumab (200mg/10mL solution) will be administered by intratumoral injection at a maximum total dose of 40 mg (= 2 ml of a 200mg/10ml solution) on day 1 followed by a subsequent intratumoral injections on day 15, 29, 43, 57 and 71. Total administered dose of avelumab (200mg/10mL solution) will be up to 2.0 mL per treatment. Injected volume per lesion will range from 0.05 mL for lesions \< 0,5 cm to 2.0 mL for lesions \> 5 cm in longest diameter. Injection of all lesions in individual patients will not be required.

DRUG

Ipilimumab 5 MG/ML

Ipilimumab (50mg/10mL solution) will be administered by intratumoral injection at a maximum total dose of 10 mg (= 2 ml of a 50mg/10ml solution) on day 1 followed by a subsequent intratumoral injections on day 15, 29, 43, 57 and 71. Total administered dose of ipilimumab (50mg/10mL solution) will be up to 2.0 mL per treatment. Injected volume per lesion will range from 0.05 mL for lesions \< 0,5 cm to 2.0 mL for lesions \> 5 cm in longest diameter. Injection of all lesions in individual patients will not be required. Determination of ipilimumab (50mg/10mL solution) injection volume based on lesion size

DRUG

Pembrolizumab 100 MG in 4 ML Injection

The first administration of pembrolizumab 200 mg (100 mg/4mL solution) by the intravenous route during 30 minutes will be administered on day 1. The second administrations of pembrolizumab 200 mg will be administered by a 30 minutes intravenous infusion on day 21, and thereafter every 21 days (or up to ± 3 days before or after the scheduled date if necessary) days.

OTHER

CD1c (BDCA-1)+ / CD141 (BDCA-3)+ myDC

CD1c (BDCA-1)+ / CD141 (BDCA-3)+ myDC will be administered by intratumoral injection in the lesions that were injected by avelumab en ipilimumab on day 1 (approximately 24 hours after intratumoral injection of avelumab en ipilimumab). The total administered CD1c (BDCA-1)+/ CD141 (BDCA-3)+ myDC volume will be up to 4.0 mL per intratumoral treatment session. Injected volume per lesion (skin-, soft tissue or lymph-node metastases) will range from 0.1 mL for lesions \< 0,5 cm to 4.0 mL for lesions \> 5 cm in longest diameter. Injection of all lesions in an individual patient will not be required. The determination of CD1c (BDCA-1)+ / CD141 (BDCA-3)+ myDC injection volume is based on lesion size. When lesions are clustered together, they are injected as a single lesion according to the table for determination of CD1c (BDCA-1)+ / CD141 (BDCA-3)+ myDC injection volume based on lesion size.

Sponsors & Collaborators

  • Universitair Ziekenhuis Brussel

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-22
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Diseases

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 NCT04571632 on ClinicalTrials.gov