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Biliary Tract CancerPhase 2TRAP-BTCNCT06178445

Efficacy and Safety of GemCis Plus Trastuzumab Plus Pembrolizumab in Previously Untreated HER2-positive Biliary Tract Cancer

A Phase 2 study testing SOC plus trastuzumab and pembrolizumab in people with Biliary Tract Cancer and HER2 Gene Mutation, run by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest at 8 sites in Germany.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a multicenter, single arm, prospective, open-label phase II trial investigating the clinical activity triplet regimen consisting of a combination of chemotherapy (gemcitabine/cisplatin) + trastuzumab + pembrolizumab as first-line treatment for cholangiocarcinoma and gallbladder cancer patients. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Biliary Tract Cancer, HER2 Gene Mutation, HER2
What is being tested?
SOC plus trastuzumab and pembrolizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
8 sitesGermany
Study dates
17 Apr 2024to Jul 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participant provides written informed consent.
  • 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
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  • Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 7 days prior to the first dose of study intervention.
  • Male Participants must agree to use a contraception as detailed in Appendix 3 of this protocol during the treatment period and for at least 7 months after the last dose of study treatment and refrain from donating sperm during this period.
  • Female Participants are eligible to participate if they are not pregnant (see Appendix 3), not breastfeeding, and at least one of the following conditions applies:
  • Not a woman of childbearing potential (WOCBP) as defined in Appendix 3 OR
  • A WOCBP who agrees to follow the contraceptive guidance as given in Appendix 3 during the treatment period and for at least 7 months after the last dose of study intervention
  • Participant has measurable disease based on RECIST v1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
  • Have adequate organ function as defined in the following table (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
  • 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.
  • 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.

Who cannot join

  • 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 5.2.
  • Participant has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137).
  • NOTE: Up to 4 cycles of prior anti-cancer therapy are allowed. In case of other anti-cancer treatment, at study inclusion patients must be switched to study treatment as defined in protocol section 5.2.
  • Participant has received prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.
  • Participant has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
  • Participant is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.
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  • NOTE: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.
  • Participant has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
  • Participant has known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ, excluding carcinoma in situ of the bladder, that have undergone potentially curative therapy are not excluded.
  • Participant has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention.
  • Participant has severe hypersensitivity (≥grade 3) to pembrolizumab, trastuzumab, gemcitabine, cisplatin and/or any of their excipients.
  • 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.
  • Participant is considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease on High Resolution Computed Tomography (HRCT) scan, previous allogenic bone marrow/blood transplantation or any psychiatric disorder or substance abuse that prohibits obtaining informed consent
  • Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities § 40 Abs. 1 S. 3 Nr. 4 AMG.
  • Patients who are unable to consent because they do not understand the nature, significance and implications of the clinical trial and therefore cannot form a rational intention in the light of the facts [§ 40 Abs. 1 S. 3 Nr. 3a AMG].
  • Patients who are dependent on the sponsor, the investigator or the trial site.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Germany8 sites

  • Universitätsklinikum Augsburg

    Augsburg

  • Charité Universitätsmedizin

    Berlin

  • Krankenhaus Nordwest (KHNW)

    Frankfurt

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau

  • Universitätsklinikum Göttingen

    Göttingen

  • Hämatologisch-Onkologische Praxis Eppendorf (HOPE)

    Hamburg

  • Medizinische Hochschule Hannover

    Hanover

  • LMU München

    München

Other trials in Germany

About this study

This is a multicenter, single arm, prospective, open-label phase II trial investigating the clinical activity triplet regimen consisting of a combination of chemotherapy (gemcitabine/cisplatin) + trastuzumab + pembrolizumab as first-line treatment for cholangiocarcinoma and gallbladder cancer patients.

Patients suffering from previously untreated HER2 (human epidermal growth factor receptor 2) positive, unresectable cholangiocarcinoma and gallbladder cancer will be included in the study and are scheduled to receive triplet regimen consisting of a combination of pembrolizumab, trastuzumab and gemcitabine/cisplatin (GemCis).

Being tested
SOC plus trastuzumab and pembrolizumab
Keywords
cholangiocarcinoma, gallbladder carcinoma, HER2-positive, HER2
Medical subject headings
Biliary Tract Neoplasms, Cholangiocarcinoma, Gallbladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SOC plus trastuzumab and pembrolizumabDrug

    SOC treatment with gemcitabine/cisplatin in combination with trastuzumab and pembrolizumab

Study groups in NCT06178445
Study groupRoleWhat they receive
SOC treatment with gemcitabine/cisplatin in combination with trastuzumab and pembrolizumabExperimental* Gemcitabine: 1000 mg/m2 on day 1 and day 8 of each 21-days cycle (Q3W) * Cisplatin: 25 mg/m2 on day 1 and day 8 of each 21-days cycle * Trastuzumab: initial dose 8 mg/kg, then 6 mg/kg on day 1 of each 21-days cycle * Pembrolizumab: 200 mg on day 1 of each 21-days cycle
Receives: Drug: SOC plus trastuzumab and pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ORR

    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

    Measured: 6 months

Secondary outcomes (6)

  1. PFS

    defined as time from enrolment until the date of first objectively documented progression according to RECIST v1.1

    Measured: through study completion, an average of 2 years

  2. OS

    defined as time from enrolment to the date of death of any cause

    Measured: through study completion, an average of 2 years

  3. PFS rate at 6 months

    defined as proportion of patients without progression after 6, 9 and 12 months

    Measured: 6 months

  4. PFS rate at 9 months

    defined as proportion of patients without progression after 9 months

    Measured: 9 months

  5. PFS rate at 12 months

    defined as proportion of patients without progression after 12 months

    Measured: 12 months

  6. The incidence, nature, causality, seriousness, and severity of adverse events using NCI CTCAE 5.0

    Safety of treatment

    Measured: through study completion, an average of 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Dec 2023
  2. Study start17 Apr 2024
  3. Primary completionDec 2026 (estimated)
  4. Study completionJul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
All eligible patients will receive SOC treatment with gemcitabine/cisplatin in combination with trastuzumab and pembrolizumab.
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06178445
Sponsor's protocol ID
TRAP-BTC
Other IDs
EU CT number
Acronym
TRAP-BTC
Status last verified
Mar 2026
First submitted
11 Dec 2023
Last updated
27 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No IPD will be shared

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SOC plus trastuzumab and pembrolizumab in people with Biliary Tract Cancer and HER2 Gene Mutation, run by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest at 8 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06178445.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.

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