Agnostic Therapy in Rare Solid Tumors

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

28

Participants

Timeline

Start Date

July 1, 2024

Primary Completion Date

July 31, 2026

Study Completion Date

May 31, 2028

Conditions
Urachal CancerParathyroid CarcinomaFibrolamellar CarcinomaAngiosarcomaSecretory Carcinoma of BreastAnal NeoplasmsMetaplastic Breast CarcinomaTranslocation Renal Cell CarcinomaCarcinosarcomaSmall Intestine NeoplasmsCholangiocarcinomaSertoli-Leydig Cell TumorAdenoid Cystic CarcinomaMesotheliomaNeuroblastomaAdrenal Gland NeoplasmsPenile NeoplasmsApocrine CarcinomaFibrosarcomaCancer of Unknown PrimaryHemangioblastomaThyroid NeoplasmsHepatoblastomaFallopian Tube NeoplasmsLeiomyosarcomaVaginal NeoplasmsNeurofibrosarcomaGallbladder NeoplasmsOsteosarcomaBiliary Tract NeoplasmsClear Cell Endometrial CancerYolk Sac TumorVulvar NeoplasmsKaposi SarcomaOvarian Epithelial CancerSoft Tissue SarcomaUrethral NeoplasmsGranulosa Cell TumorPrimitive Neuroectodermal TumorNeuroendocrine TumorsTrophoblastic Tumor
Interventions
DRUG

Nivolumab

"The intervention consists of administering Nivolumab 480 mg intravenously every 4 weeks, with a +5 day window for postponement but not for advancement of treatment. Treatment will continue until limiting toxicity, disease progression, or for a maximum period of 12 months (13 cycles) as maintenance therapy, provided the patient maintains stable disease, a partial response, or a complete response. Patients who are off treatment for more than 56 days (2 cycles) due to Nivolumab-related toxicities or other clinical issues will be discontinued from the protocol.~After 12 months of treatment or in the event of study discontinuation for any reason, patients will be followed by the research team via telephone every 60 days, with a +/- 7 day window, until death."

Trial Locations (8)

70390-903

DF Star, Brasília

60170-170

Hospital São Carlos, Fortaleza

41253-190

Hospital São Rafael, Salvador

80420-090

Hospital Santa Cruz, Curitiba

52010-010

IDOR Recife, Recife

22281-100

Instituto D'Or de Pesquisa e Ensino, Rio de Janeiro

04.501-000

Instituto D'or de Pesquisa e Ensino, São Paulo

05403-010

Instituto do Câncer do Estado de São Paulo - ICESP, São Paulo

All Listed Sponsors
collaborator

Financiadora de Estudos e Projetos

OTHER

lead

Instituto do Cancer do Estado de São Paulo

OTHER

NCT06638931 - Agnostic Therapy in Rare Solid Tumors | Biotech Hunter | Biotech Hunter