Neoadjuvant Pembrolizumab and Porustobart in Resectable pMMR/MSS Colon Cancer
A Phase 2, Open-Label, Multicenter, Randomized Trial Evaluating the Efficacy and Safety of Different Schedules of Neoadjuvant Pembrolizumab and Porustobart in Patients With Resectable pMMR/MSS Colon Cancer
The goal of this clinical trial is to learn if giving two medicines together, porustobart and pembrolizumab, before surgery can treat a common type of colon cancer called microsatellite stable (MSS) colon cancer in adults. This type of cancer can be removed with surgery and has not spread to other parts of the body. Both medicines work by helping the immune system fight cancer.
The main questions this study wants to answer:
How well do the medicines destroy the cancer before surgery? What side effects do participants have when taking the medicines?
Researchers will compare two groups to see which treatment schedule works better and is safer. Both groups get pembrolizumab. One group gets one dose of porustobart (Day 1 only), and the other group gets two doses (Day 1 and Day 22).
Participants will:
Complete certain tests and procedures to make sure they are eligible Get the medicines through a vein on Day 1 and Day 22 then have surgery 6-9 weeks after starting treatment Return for checkups and tests every 6 months for up to 3 years after surgery
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 2
Kontakter og lokationer
Studiekontakt
- Navn: Medical Monitor
- Telefonnummer: 617-982-2331
- E-mail: SOL1-201@solsticeoncology.com
Studiesteder
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Anderlecht, Belgien
- Investigator Site
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Bonheiden, Belgien
- Investigator Site
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Ghent, Belgien
- Investigator Site
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Leuven, Belgien
- Investigator Site
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Liège, Belgien
- Investigator Site
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Ostend, Belgien
- Investigator Site
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Woluwe-Saint-Lambert, Belgien
- Investigator Site
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Aberdeen, Det Forenede Kongerige
- Investigator Site
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Cardiff, Det Forenede Kongerige
- Investigator Site
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Glasgow, Det Forenede Kongerige
- Investigator Site
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Leeds, Det Forenede Kongerige
- Investigator Site
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London, Det Forenede Kongerige
- Investigator Site
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California
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Los Angeles, California, Forenede Stater, 90033
- Investigator Site
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Florida
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Tampa, Florida, Forenede Stater, 33612
- Investigator Site
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Illinois
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Chicago, Illinois, Forenede Stater, 60637
- Investigator Site
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Maryland
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Baltimore, Maryland, Forenede Stater, 21287
- Investigator Site
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02114
- Investigator Site
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New York
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New York, New York, Forenede Stater, 10016
- Investigator Site
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New York, New York, Forenede Stater, 10021
- Investigator Site
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New York, New York, Forenede Stater, 10027
- Investigator Site
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Ohio
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Cleveland, Ohio, Forenede Stater, 44106
- Investigator Site
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Tennessee
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Nashville, Tennessee, Forenede Stater, 37232
- Investigator Site
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Washington
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Seattle, Washington, Forenede Stater, 98109
- Investigator Site
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Amsterdam, Holland
- Investigator Site
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Milan, Italien
- Investigator Site
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Naples, Italien
- Investigator Site
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Pisa, Italien
- Investigator Site
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Barcelona, Spanien
- Investigator Site
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L'Hospitalet de Llobregat, Spanien
- Investigator Site
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Madrid, Spanien
- Investigator Site
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
≥18 years of age at consent
Adenocarcinoma of the colon (rectosigmoid considered non-rectal); pMMR/MSS status
Any T3 or T4, N any, M0; disease amenable to surgical resection
ECOG Performance Status 0-1
Adequate tumor tissue sample with associated pathology report
Adequate hematologic, hepatic, and renal function
Reproductive status/contraception requirements per protocol
Exclusion Criteria:
Investigational agent within 3 weeks of first dose
Imminent or urgent need for surgery
Prior treatment with ICIs targeting CTLA-4, PD-1, or PD-L1
Systemic corticosteroid/immunosuppressive therapy within 1 week of first dose (exceptions apply)
History of severe hypersensitivity to a fully human mAb; interstitial lung disease; pneumonitis requiring corticosteroids
Active or history of autoimmune disease requiring systemic treatment within 2 years
Major surgery within 4 weeks of first dose; active infection requiring treatment
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Arm 1
Pembrolizumab IV every 3 weeks x 2 doses (Day 1, Day 22) plus porustobart x 1 dose (Day 1 only)
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Administered to: Arm 1, Arm 2
Andre navne:
Administered to: Arm 1, Arm 2
Andre navne:
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Eksperimentel: Arm 2
Pembrolizumab IV every 3 weeks x 2 doses (Day 1, Day 22) plus porustobart every 3 weeks x 2 doses (Day 1, Day 22)
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Administered to: Arm 1, Arm 2
Andre navne:
Administered to: Arm 1, Arm 2
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Major Pathologic Response (MPR) rate by Blinded Independent Pathologic Review (BIPR)
Tidsramme: Assessed from surgical resection specimen (surgery occurs Day 42-Day 63, i.e., approximately Week 6-Week 9 after first dose)
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MPR is defined as the proportion of patients with ≤10% residual tumor volume in the primary tumor and lymph nodes, as evaluated by BIPR, per treatment arm
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Assessed from surgical resection specimen (surgery occurs Day 42-Day 63, i.e., approximately Week 6-Week 9 after first dose)
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Pathologic Complete Response (pCR) rate
Tidsramme: Assessed from surgical resection specimen (Week 6-9)
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Assessed from surgical resection specimen (Week 6-9)
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Incidence of treatment-related adverse events (AEs), serious adverse events (SAEs), and immune-related AEs
Tidsramme: From informed consent through 60 days after last dose (or initiation of new anti-cancer treatment, whichever occurs first)
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From informed consent through 60 days after last dose (or initiation of new anti-cancer treatment, whichever occurs first)
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Hjernesygdomme
- Sygdomme i centralnervesystemet
- Sygdomme i nervesystemet
- Neoplasmer efter sted
- Neoplasmer
- Genetiske sygdomme, medfødte
- Tarmsygdomme
- Gastrointestinale neoplasmer
- Neoplasmer i fordøjelsessystemet
- Sygdomme i fordøjelsessystemet
- Gastrointestinale sygdomme
- Kolorektale neoplasmer
- Intestinale neoplasmer
- Neurodegenerative sygdomme
- Tyktarmssygdomme
- Heredodegenerative lidelser, nervesystem
- Rygmarvssygdomme
- Cerebellære sygdomme
- Medfødte, arvelige og neonatale sygdomme og abnormiteter
- Colon neoplasmer
- Spinocerebellare degenerationer
- Diabetes mellitus, insulinafhængig, 12
- pembrolizumab
Andre undersøgelses-id-numre
- SOL1-201
- 2026-527233-58-00 (Ctis)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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