study of pembrolizumab in classic or endemic Kaposi’s sarcoma

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Assistance Publique Hopitaux De Paris

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

22 Oct 2024 → ongoing

Decision date (initial)

2024-10-22

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

MSD International

External identifiers

EU CT number

2024-514241-10-00

EudraCT number

2016-003714-27

ClinicalTrials.gov

NCT03469804

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Therapy, Efficacy

to assess whether pembrolizumab is clinically inactive (partial+complete response probability π0<5%) or truly active (partial+complete response probability π1>30%) in classic and endemic Kaposi’s sarcoma (KS), using the Simon’s 2 stage Optimal Design.

Secondary objectives 2

1. to assess the safety profile of pembrolizumab in classic and endemic Kaposi’s sarcoma,
2. to characterize the efficacy of pembrolizumab related to pharmacodynamics assessment

Conditions and MedDRA coding

Kaposi's sarcoma

Regulatory references

Plan to share IPD

No

IPD plan description

open

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Classic or endemic histologically confirmed KS
2. Progressive disease
3. KS with more than 10 lesions or involving more than one limb segment or with involvement >3% body surface
4. .KS with at least 4 lesions>ou = 5mm
5. KS with at least 1 other cutaneous tumor available for repeated pharmacodynamics evaluation and be willing to provide tissue from cutaneous biopsy of a tumor lesion
6. At least 4 weeks washout for all KS specific therapies including chemotherapy and immunotherapy such as Interferon
7. Be 18 years of age on day of signing informed consent
8. Female subject of childbearing potential should have a negative serum XML File Identifier: IeulZ03EWkX0or3jxMs6iTJnYtU= Page 10/22 pregnancy within 72 hours prior to receiving the first dose of study medication, and a negative urine pregnancy test prior to receiving each other dose.

Exclusion criteria 10

1. • Has a known history of organ transplantation
2. • Is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment
3. • Has KS with symptomatic visceral involvement unless no other therapeutic option is available
4. • Previously received treatments with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4 antibody or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways.
5. • Uncontrolled infection with HIV, HBV, or HCV infection; or diagnosis of immunodeficiency that is related to, or results in chronic infection.
6. • Has an active infection requiring systemic therapy
7. • Has hypersensitivity to pembrolizumab/ KEYTRUDA® or any of its excipients
8. • Has had a prior anti-cancer monoclonal antibody (mAb) within last 4 weeks or who has not recovered (i.e., > Grade 1 at selection) from adverse events due to agents administered more than 4 weeks earlier.
9. • Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 3 weeks (or 5 half lives) prior to study Day 1 or who has not recovered (i.e., > Grade 1 at selection) from adverse events due to a previously administered agent
10. • Has active autoimmune disease that has required systemic treatment in the past 2 years

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. the Best Overall Response Rate (BORR) defined by the occurrence of complete response or partial response following ACTG criteria recorded from the start of treatment until 6 months or the beginning of any other specific systemic therapy for KS if it occurs before 6 months.
2. For Extension stage The primary endpoint of this stage will be the best overall response rate according to the ACTG criteria recorded from the start of treatment until 24 months or the beginning of any other specific systemic therapy for KS if it occurs before 6 months.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Assistance Publique Hopitaux De Paris

Sponsor organisation

Assistance Publique Hopitaux De Paris

Address

Porte 23, 1 Avenue Claude Vellefaux 1 Avenue Claude Vellefaux

City

Paris Cedex 10

Postcode

75475

Country

France

Scientific contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

Coordinating investigator

Public contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

Coordinating investigator

Locations

1 EU/EEA country · 10 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 5 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications