2023-505722-33-00
Recruiting
Phase 2
TRAP-BTC Efficacy and safety of GemCis plus Trastuzumab plus Pembrolizumab in previously untreated HER2-positive biliary tract cancer
Institut fuer Klinische Krebsforschung IKF GmbH9 sites in 1 country24 target enrollmentStarted: December 11, 2023Last updated:
Overview
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Institut fuer Klinische Krebsforschung IKF GmbH
- Enrollment
- 24
- Locations
- 9
- Primary Endpoint
- ORR@6, defined as proportion of subjects with complete response (CR) or partial response (RP) according to unconfirmed RECIST v1.1 at 6 months after treatment initiation.
Overview
Brief Summary
The primary objective of this trial is to assess the efficacy of the combination of SOC treatment via GemCis in combination with trastuzumab and pembrolizumab in terms of objective response rate after 6 months (ORR@6).
Eligibility Criteria
- Ages
- 18 years to 65+ years (65+ Years, 18-64 Years)
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Participant provides written informed consent.
- •Have adequate organ function as defined in protocol (Table 2).
- •Criteria for known Hepatitis B and C positive subjects Hepatitis B and C screening tests are not required unless there is a known history of HBV or HCV infection and/or as mandated by local health authority a. Hepatitis B positive subjects • Participants who are HBsAg positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load (< 100 IU/mL) prior to enrollment • Participants should remain on anti-viral therapy throughout study intervention and follow local guidelines for HBV anti-viral therapy post completion of study intervention. b. Participants with history of HCV infection are eligible if HCV viral load is undetectable at screening. • Participants must have completed curative anti-viral therapy at least 4 weeks prior to enrollment.
- •Male/female Participants who are at least 18 years of age on the day of signing informed consent.
- •Participant is, in the investigator’s judgement, willing and able to comply with the study protocol.
- •Participant has histologically confirmed diagnosis of cholangiocarcinoma or gallbladder cancer.
- •Participant is not eligible for surgery.
- •Participants must have HER2-positive disease defined as either IHC 3+ or IHC 2+, the latter in combination with FISH+, as assessed locally on primary tumor OR positively confirmed by NGS-analysis OR positively confirmed by mRNA
- •Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to
- •Evaluation of ECOG is to be performed within 7 days prior to the first dose of study intervention.
Exclusion Criteria
- •Participant has received prior systemic anti-cancer therapy. NOTE: Participants who have received up to 4 cycles of prior GemCis or any other anti-cancer treatment prior to initiation of study treatment are eligible for the study. In case of other anti-cancer treatment, at study inclusion patients must be switched to study treatment as defined in protocol section 5.
- •Participant has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.
- •Patient has inadequate cardiac function (LVEF value < 55%) as determined by echocardiography.
- •Participant has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
- •Participant has an active infection requiring systemic therapy.
- •Participant has a known history of Human Immunodeficiency Virus (HIV) infection.
- •Participant has a history or current evidence of any condition, therapy, or laboratory abnormality or other circumstance that might confound the results of the study, interfere with the participant’s participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator.
- •Participant has had an allogenic tissue/solid organ transplant.
- •Participant has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- •Participants who are pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 7 months after the last dose of trial treatment.
Outcomes
Primary Outcomes
ORR@6, defined as proportion of subjects with complete response (CR) or partial response (RP) according to unconfirmed RECIST v1.1 at 6 months after treatment initiation.
ORR@6, defined as proportion of subjects with complete response (CR) or partial response (RP) according to unconfirmed RECIST v1.1 at 6 months after treatment initiation.
Secondary Outcomes
- PFS, defined as time from enrolment until the date of first objectively documented progression according to RECIST v1.1
- OS, defined as time from enrolment to the date of death of any cause
- PFS rate at 6, 9 and 12 months (PFSR@6, PFSR@9, PFSR@12), defined as proportion of patients without progression after 6, 9 and 12 months
- Assessment of safety of the treatment as determined by the incidence, nature, causality, seriousness, and severity of adverse events using NCI CTCAE 5.0
Investigators
Clinical Trial project manager
Scientific
Institut fuer Klinische Krebsforschung IKF GmbH
Study Sites (9)
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