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Study of Tremelimumab Alone or Combined With Olaparib for Patients With Persistent EOC (Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma)

9. april 2021 opdateret af: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

An Open Label Dose Escalation/Expansion Study of Tremelimumab Alone or Combined With Olaparib for Recurrent or Persistent EOC (Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma)

This study will be looking at what dose of tremelimumab and olaparib is safe and effective in patients with persistent EOC (Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This clinical trial was initially intended to be a Phase 1/2 trial, but the trial never moved forward to Phase 2 prior to termination.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

24

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21231
        • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Signed informed consent form
  2. Age ≥ 18 years
  3. Recurrent or persistent EOC (epithelial ovarian, fallopian tube or primary peritoneal carcinoma)
  4. Have archival tissue or willingness to undergo a tumor biopsy
  5. Have measurable disease
  6. Have had one prior taxane-platinum-based chemotherapeutic regimen
  7. Have had a treatment-free interval following platinum-based therapy of less than 12 months, have progressed during platinum-based therapy, or had persistent disease after a platinum-based regimen
  8. Have received hormonal therapy
  9. ECOG Performance Status of 0 to 1
  10. Ability to take oral medications
  11. HIV, HTLV-1, HBV, and HCV negative
  12. Adequate organ and bone marrow function as defined by study-specified laboratory tests
  13. Normal blood coagulation parameters
  14. Life expectancy greater than 16 weeks
  15. Must use acceptable form of birth control through the study and for 28 days after final dose of study drug
  16. Willing and able to comply with study procedures

Exclusion Criteria:

  1. Prior therapy with an anti-CTLA-4 antibody or PARP inhibitor
  2. Active infection requiring antibiotics
  3. Active autoimmune disease
  4. Active and uncontrolled intercurrent illness
  5. History of other cancers within the past 5 years
  6. Systemically active steroid use
  7. Receiving systemic chemotherapy or radiotherapy within 4 weeks prior to the first dose of study drug
  8. Use of ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, telithromycin, clarithromycin and nelfinavir
  9. Requirement for chronic parenteral hydration/nutrition
  10. Vaccination with live attenuated vaccine within 1 month prior to first dose of study drug
  11. Patients with untreated brain metastases, treated brain metastases that are not stable, leptomeningeal disease, or seizures uncontrolled with standard medical therapy
  12. Patients with myelodysplastic syndrome/acute myeloid leukaemia
  13. History of diverticulitis
  14. History of bleeding disorder or diathesis.
  15. Serious or nonhealing wound, ulcer, bone fracture, or osteonecrosis of the jaw
  16. Major surgical procedure within 28 days of study enrollment, or anticipated while on study.
  17. Pregnant or breast feeding woman

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

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
Eksperimentel: Arm A: Tremelimumab Alone
25 patients will receive tremelimumab alone at 10 mg/kg IV every 4 weeks for 7 doses then every 12 weeks until disease progression.
Medicin: Tremelimumab
Eksperimentel: Arm B1: DESE Tremelimumab and Olaparib
18 patients will receive tremelimumab (3 or 10 mg/kg IV) every 4 weeks for 7 doses then every 12 weeks and olaparib (150 or 300 mg orally twice a day) until disease progression.
Medicin: Tremelimumab
Medicin: Olaparib
Andre navne:
  • LYNPARZA
Eksperimentel: Arm B2: Tremelimumab and Olaparib
25 patients will receive tremelimumab (every 4 weeks for 7 doses then every 12 weeks) and olaparib (daily) until disease progression. Dose of tremelimumab and olaparib will be determined during the DESE (Arm B1).
Medicin: Tremelimumab
Medicin: Olaparib
Andre navne:
  • LYNPARZA

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Adverse events as a measure of the safety and tolerability profile of tremelimumab in combination with olaparib
Tidsramme: 4 years
Number of participants experiencing study drug-related dose limiting toxicities (DLTs). Dose escalation (phase I) portion of the trial only.
4 years
Fold change from baseline in the ratio of peripheral CD4+ICOShi T cells and Regulatory T cells
Tidsramme: 4 years
Dose escalation (phase I) portion of the trial only.
4 years
Maximum Tolerated Dose (MTD) of tremelimumab combined with olaparib
Tidsramme: 4 years
Dose escalation (phase I) portion of the trial only.
4 years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Samlet overlevelse (OS)
Tidsramme: 4 år
OS vil blive målt fra datoen for første dosis til døden eller afslutningen af ​​opfølgningen (OS vil blive censureret på den dato, hvor forsøgspersonen sidst var kendt for at være i live for forsøgspersoner uden dokumentation for død på analysetidspunktet). Estimering baseret på Kaplan-Meier-kurven.
4 år
Progression Free Survival (PFS) Rate at 6 months by RECIST
Tidsramme: 6 months
PFS rate is defined as the percentage of patients with disease progression (PD or relapse from CR as assessed using RECIST 1.1 criteria) or death due to any cause at 6 months. Per RECIST 1.1 criteria, Complete Response (CR) = disappearance of all target lesions, Partial Response (PR) is =>30% decrease in sum of diameters of target lesions, Progressive Disease (PD) is >20% increase in sum of diameters of target lesions, Stable Disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions. Estimation based on the Kaplan-Meier curve.
6 months
Progression Free Survival (PFS) Rate at 6 months by irRECIST
Tidsramme: 6 months
PFS rate is defined as the percentage of patients with disease progression (irPD or relapse from irCR as assessed using irRECIST criteria) or death due to any cause at 6 months. Per irRECIST criteria, irCR = disappearance of all lesions, irPR is =>30% decrease in tumor burden, irPD is >20% increase in tumor burden compared with nadir, irSD is <30% decrease in tumor burden compared with baseline cannot be established nor <20% increase compared with nadir. Estimation based on the Kaplan-Meier curve.
6 months
Objective Response Rate (ORR) by RECIST
Tidsramme: 4 years
Objective Response Rate (ORR) is defined as the percentage of patients achieving a complete response (CR) or partial response (PR) based on RECIST 1.1 criteria. Per RECIST 1.1 criteria, CR = disappearance of all target lesions and PR is =>30% decrease in sum of diameters of target lesions.
4 years
Objective Response Rate (ORR) by irRECIST
Tidsramme: 4 years
Objective Response Rate (irORR) is defined as the percentage of patients achieving a complete response (irCR) or partial response (irPR) based on irRECIST criteria. Per irRECIST criteria, irCR = disappearance of all lesions and irPR is =>30% decrease in tumor burden.
4 years
Duration of Response by RECIST
Tidsramme: 4 years
Number of months from the start date of PR or CR (whichever response is recorded first) and subsequently confirmed to the first date that recurrent or progressive disease or death is documented. Per RECIST 1.1 criteria, CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions, and PD is >20% increase in sum of diameters of target lesions.
4 years
Duration of Response by irRECIST
Tidsramme: 4 years
Number of months from the start date of irPR or irCR (whichever response is recorded first) and subsequently confirmed to the first date that recurrent or progressive disease or death is documented. Per irRECIST criteria, irCR = disappearance of all lesions, irPR is =>30% decrease in tumor burden, and irPD is is >20% increase in tumor burden compared with nadir.
4 years
Disease Control Rate (DCR)
Tidsramme: 4 years
DCR is defined as the number of patients achieving a complete response (CR) or partial response (PR) or stable disease (SD) based on RECIST 1.1 criteria at any time during the study. CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions, PD is >20% increase in sum of diameters of target lesions, SD is <30% decrease or <20% increase in sum of diameters of target lesions. Estimation based on the Kaplan-Meier curve.
4 years
Progression-Free Survival (PFS)
Tidsramme: 4 years
PFS is defined as the number of patients with disease progression (progressive disease [PD] or relapse from complete response [CR] as assessed using RECIST 1.1 criteria) or death due to any cause. Per RECIST 1.1 criteria, CR = disappearance of all target lesions, Partial Response (PR) is =>30% decrease in sum of diameters of target lesions, Progressive Disease (PD) is >20% increase in sum of diameters of target lesions, Stable Disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions. Estimation based on the Kaplan-Meier curve.
4 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Samarbejdspartnere

AstraZeneca
MedImmune LLC

Efterforskere

  • Ledende efterforsker: Stephanie Gaillard, MD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

8. januar 2016

Primær færdiggørelse (Faktiske)

5. marts 2020

Studieafslutning (Faktiske)

5. marts 2020

Datoer for studieregistrering

Først indsendt

26. juni 2015

Først indsendt, der opfyldte QC-kriterier

29. juni 2015

Først opslået (Skøn)

30. juni 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. april 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. april 2021

Sidst verificeret

1. april 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • J15113
  • IRB00064379 (Anden identifikator: JHM IRB)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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