ClinicalTrials.gg
CompletedNCT03260712Updated Nov 3, 2023

Pembrolizumab in Biliary Tract Cancer

A Phase 2 interventional study of Pembrolizumab and Cisplatin in Biliary Tract Cancer, Metastatic Cancer and Advanced Cancer, sponsored by European Organisation for Research and Treatment of Cancer - EORTC. Completed at 7 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-03.

Primary conditionGallbladder NeoplasmsRegistry: Biliary Tract NeoplasmsReclassifiedWhy we changed it
Registry
Biliary Tract Neoplasms — the first condition term the registry derived for this study.
ClinicalTrials.gg
Gallbladder Neoplasms
Why
  1. The study's listed conditions name Gallbladder Neoplasms, a narrower term within Biliary Tract Neoplasms.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by European Organisation for Research and Treatment of Cancer - EORTC · Phase 2, Interventional, and Treatment

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Phase
Phase 2
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 22 studies in Gallbladder Neoplasms with a site in United Kingdom — 4 open to participants now, 7 under way, 5 of them phase 3. Gallbladder Neoplasms · United Kingdom.

Enrollment
16th of 20
50 · median 249
Started
2020
with 2 others
Phase 2
4 of 22
none open now
Registered
9th of 22
by date
Lead sponsor
1 of 22
European Organisation for Research and Treatment of Cancer - EORTC

Among the 22 studies in Gallbladder Neoplasms with a site in United Kingdom, this one is the 16th largest by enrollment of the 20 interventional ones that give a count, is one of 3 that started in 2020, is one of 4 in phase 2, and was the 9th registered.

Gallbladder Neoplasms

301 studies on the registry are indexed under Gallbladder Neoplasms; 65 are open to participants now.

Browse Gallbladder Neoplasms studies →

Open to participants now

4 of the 22 studies in Gallbladder Neoplasms with a site in United Kingdom are open now. Recruiting first, the newest first:

All 4 open studies →

A study can be open while its sites in United Kingdom have not opened yet or have stopped. Only those recruiting at a site in United Kingdom →

Who these studies take

Of the 43 Gallbladder Neoplasms studies recruiting now, 24 (56%) set no upper age limit and 8 (19%) stop at 75 or younger; 4 take children under 18; 4 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 22 studies in Gallbladder Neoplasms with a site in United Kingdom, or all of them as a file.
02

Study summary

This is a single-arm, multi-centre, phase II study in biliary tract cancer (BTC) patients. The main objective is to detect an increase in progression-free survival rate at 6 months (according to RECIST version 1.1) from 60% in patients with BTC treated with standard chemotherapy (CT) approach to 75% when treated with CT combined with pembrolizumab.

Read the detailed description

Primary endpoint: PFS rate at 6 months according to RECIST 1.1.

Secondary endpoints:

  • Best overall response rate (according to RECIST 1.1 and iRECIST)
  • Response duration and stable disease duration (according to RECIST 1.1 and iRECIST)
  • PFS rate at 6 months according to iRECIST
  • PFS according to RECIST 1.1 and iRECIST
  • Overall survival (OS)
  • Toxicity of treatment (Common Toxicity Criteria CTCAE 5.0)
  • Safety analysis: A safety analysis will be done when at least 10 patients have completed at least one cycle of the three- drug combination.

Events of clinical interest for this safety analysis are the following:

  • At least Grade 2 or higher CTCAE 5.0 signs of acute renal failure
  • Grade 3 or 4 liver dysfunction defined as elevation of liver transaminases (AST and ALT) and alkaline phosphatase, increased bilirubin
  • Grade 3 or 4 gastrointestinal disorders specifically colitis, diarrhea and stomatitis
  • Grade 3 or 4 dyspnea, dry cough and pneumonia
  • Grade 3 or 4 sepsis
  • Grade 3 or 4 skin toxicity If 4 out of these 10 patients experience any of the above, this will trigger an IDMC review. This cut-off is based on: 1) previous ABC-02 study where 57% of patients experienced a grade 3 or 4 toxicity at 12 weeks of treatment; and 2) KEYNOTE 028 where 17% of patients experienced grade 3 or 4 toxicity The primary analysis of efficacy endpoints will be performed in the protocol population.
  • PFS rate at 6 months will be estimated using Kaplan Meier estimate at the time point of interest. The lower bound of the one-sided 90% confidence interval (CI) will be calculated by Greenwood's estimation of the standard deviation. If the lower bound of the one-sided 90% CI is above 60%, it will be concluded that the new treatment is effective enough to warrant further evaluation in a phase III trial. Assuming exponential distributions for both PFS and for the risk of drop-out, power with a total sample size of 50 patients when the primary test is performed using Kaplan Meier analyses will be around 82% for a drop-out rate of 5% at 6 months and still above 80% for a drop-out rate of 10% at 6 months. The one-sided type I error will be respectively 9.33% and 9.02%.
  • PFS rate at 6 months according to iRECIST will be estimated using Kaplan Meier estimate and the one-sided 90% confidence interval (CI) will be calculated by Greenwood's estimation of the standard deviation.
  • BOR rate according to RECIST 1.1 and iBOR rate according to iRECIST will be displayed (point estimate) with their exact two-sided 95% confidence intervals. Response duration and stable disease duration according to RECIST 1.1 and iRECIST will be graphically displayed using swimmer plots and bar charts.
  • Progression free survival according to RECIST 1.1 and iRECIST and overall survival curves will be estimated using the Kaplan-Meier technique. The safety analyses will be performed in the Safety population. The worst toxicity grade per patient over the treatment period according to the CTCAE criteria version 5.0 will be displayed.
03

Conditions studied

  • Biliary Tract Cancer
  • Metastatic Cancer
  • Advanced Cancer
  • Gallbladder Cancer

Browse trials for

Keywords

  • biliary tract cancer
  • metastitic cancer
  • advanced cancer
  • pembrolizumab
  • cisplatin
  • gemcitabine
  • gallbladder cancer
04

In context

Gallbladder Neoplasms Reclassified

301 studies on the registry are indexed under Gallbladder Neoplasms; 65 are open to participants now.

This study's enrollment of 50 is below the median of 56 across 222 interventional studies indexed under Gallbladder Neoplasms.

Browse Gallbladder Neoplasms studies →

Lead sponsor

European Organisation for Research and Treatment of Cancer - EORTC is the lead sponsor of 352 studies on the registry; 23 are open to participants now.

Compared within Gallbladder Neoplasms, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Biliary Tract Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • A histopathological / cytological diagnosis of non-resectable or recurrent / biliary tract carcinoma (intra- or extra-hepatic) or gallbladder
  • Availability of archival FFPE tumor tissue for biobanking
  • by CT/MRI ( 1.1) within 28 days of enrollment
  • performance status 0, 1
  • Age ≥ 18 with estimated >3 months
  • Adequate hematological function: screening labs should be performed within 14 days (± 3 days) prior to enrollment:
  • ≥ 10 g/dl* (prior transfusions for patients with low hemoglobin are allowed)
  • White blood cell (WBC) ≥ 3.0 x 109/L
  • (ANC) ≥ 1.5 x 109/L
  • count ≥ 100 x 109/L
  • Adequate liver function: screening labs should be performed within 14 days (± 3 days) prior to enrollment:
  • Total ≤ 1.5 x (ULN)
  • and/or AST \& alkaline phosphatase ≤ 5 x ULN
  • Adequate renal function: screening labs should be performed within 14 days (± 3 days) prior to enrollment:
  • Serum creatinine \< 1.5 x ULN
  • and a calculated ≥ 45 mL/min (using formula). If the calculated GFR is below 45 mL/min, isotope EDTA confirmation of adequate renal function is required (see Appendix F). If isotope EDTA methods are not available, then a 24-hour urine creatinine clearance can be used.
  • Adequate coagulation: screening labs should be performed within 14 days (± 3 days) prior to enrollment:
  • (INR) or Prothrombin Time (PT): ≤ 1.5xULN unless patient is receiving anticoagulant therapy as long as PT or Partial Thromboplastin Time (PTT) is within therapeutic range of intended use of anticoagulants
  • Adequate biliary drainage with C-reactive protein (CRP) levels in normal ranges (based on institution's standard): screening labs should be performed within 14 days (± 3 days) prior to enrollment
  • Patient is not currently participating and receiving study therapy or has not participated in a study of an agent and received study therapy or used an investigation device within 4 weeks prior to enrollment
  • Women of child bearing potential () must have a negative serum (or urine) pregnancy test within 72 hours prior to the first dose of study treatment.
  • Patients of childbearing / should use adequate measures, as defined by the investigator, during the study treatment period and for at least 6 months after the last study treatment. A highly effective method of birth control is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly. Such methods include:
  • Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal)
  • Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable)
  • Intrauterine device (IUD)
  • Intrauterine hormone-releasing system (IUS)
  • Bilateral tubal occlusion
  • Vasectomised partner
  • Sexual abstinence. Note: abstinence is acceptable if this is established and preferred contraception for the patient and is accepted as a local standard.
  • Female subjects who are breast feeding should discontinue nursing prior to the first dose of study treatment and until 120 days after the last study treatment.
  • Before patient enrollment, written must be given according to ICH/GCP, and national/local regulations.

Exclusion criteria

Exclusion Criteria:

  • Patients with ascites grade 2 or higher
  • B or C hepatic impairment
  • Incomplete recovery from previous surgery or unresolved biliary tract obstruction
  • Active infection requiring therapy. Antibiotic treatment should have been completed 5 days before enrollment
  • Patients who are candidates for curative surgery
  • History of (non-infectious) pneumonitis that required or current pneumonitis. No history of or current interstitial lung disease
  • Active disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
  • Diagnosis of immunodeficiency, systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment
  • Known history of (HIV), active or
  • Patients with hyperthyroidism or hypothyroidism unless stable on hormone replacement
  • History of another or a concurrent malignancy. Exceptions include patients who have been disease-free for 5 years, or patients with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible, for example cervical cancer in situ.
  • Patients who received treatment with within 30 days prior to the first dose of study medication. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, shingles, yellow fever, seasonal flu, H1N1 flu, rabies, BCG and typhoid vaccine.
  • Prior treatment with any anti-CTLA4 monoclonal antibody or , or PD-L1 or PD-L2 agent. Examples of PD-1 inhibitors (include, but are not limited to): pembrolizumab (Merck); Nivolumab (also known as BMS-936558, MDX-1106, ONO-4538) (Bristol-Myers Squibb); Pidilizumab (CT-11) (Cure-Tech/Teva); and AMP-224 (Amplimmune). Examples of PD-L1 inhibitors (include, but are not limited to): BMS-936559 (also known as MDX-1105) (Bristol-Myers Squibb); MPDL3280A (also known as RG7446) (Roche Genentech); and MEDI4736 (MedImmune).
  • Prior systemic chemotherapy for locally advanced or disease.
  • Prior chemotherapy is allowed if the last treatment was completed at least 6 months before trial entry and neither gemcitabine nor cisplatin were given. Also the following treatment modalities are allowed within the rules described (provided there has been a full recovery):
  • Surgery - patients may have undergone a non-curative operation (i.e. R2 resection [with macroscopic residual disease] or palliative bypass surgery only). Patients who have previously undergone curative surgery, must have evidence of non-resectable disease relapse requiring systemic chemotherapy prior to study entry.
  • Radiotherapy - patients may have received prior radiotherapy (with or without radiosensitising low-dose chemotherapy) for localised disease. However, there must be clear evidence of disease progression prior to inclusion in this study.
  • Photodynamic therapy (PDT) for localized disease only with no evidence of metastatic disease - patients may have received prior PDT, provided the patient has fully recovered and at least 28 days have elapsed since the PDT and there is clear evidence of disease progression at the local site or disease or at a new metastatic site.
  • PDT for localised disease to relieve biliary obstruction in the presence of metastatic disease - patients may have received prior PDT provided the patient has fully recovered and at least 28 days have elapsed since the PDT. Patients may enter trial provided the non-PDT treated lesion(s) only are followed for response assessment.
  • Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before enrollment in the trial.
Terms in these criteria, in plain language(30)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Reproductive potential

Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.

Criteria about it usually ask for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Child-Pugh class

A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

PD-1, PD-L1 and checkpoint inhibitors

PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.

PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

06

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    CisGem + pembrolizumab

    Patients will be enrolled in the experimental arm and will receive CisGem \[25mg/m2 cisplatin + 1000mg/m2 gemcitabine, on days 1 and 8 of a 21 day cycle\] plus 200 mg pembrolizumab (fixed dose) on day 1 of a 21 day cycle.

    Drug: Pembrolizumab · Drug: Cisplatin · Drug: Gemcitabine

Interventions

  • The dose of pembrolizumab in this trial is 200 mg Q3W.

    Also known as: Anti-PD-1

  • 25mg/m2 cisplatin on days 1 and 8 of a 21 day cycle

  • 1000mg/m2 gemcitabine on days 1 and 8 of a 21 day cycle

07

What researchers measure

Primary outcomes

  1. Detection of progression-free survival (PFS) rate at 6 months defined according to RECIST 1.1.

    The main objective is to detect an increase in progression-free survival (PFS) rate at 6 months (according to RECIST version 1.1) from 60% in patients with BTC treated with standard chemotherapy approach to 75% when treated with CT combined with pembrolizumab.

    Time frame: At 6 months

Secondary outcomes

  1. Best overall response rate (according to RECIST 1.1) and overall response

    Assessing both short term and long term outcome of patients receiving this combined treatment

    Time frame: Up to 120 days after last administration of Pembrolizumab

  2. Toxicity (according to CTCAE 4.03)

    Establishing the safety of standard chemotherapy combined with pembrolizumab in these patients

    Time frame: Up to 120 days after last administration of Pembrolizumab

  3. Progression free survival rate at 6 months according to iRECIST

    Time frame: At 6 months

Other outcomes

  1. Immunological response (cytokines, lymphocyte phenotype, immunoglobulins)

    Assessment of immunological responses (cytokines, lymphocyte phenotype, immunoglobulins)

    Time frame: Up to 2 years after start of study treatment

  2. Pathological predictive factors for response and toxicity (TCR Sequencing, FACs, RNASeq, nanostring)

    Evaluation of pathological predictive factors for response and toxicity

    Time frame: Up to 2 years after start of study treatment

  3. Clinical predictive factors for response and toxicity (TCR Sequencing, FACs, RNASeq, nanostring)

    Evaluation of clinical predictive factors for response and toxicity

    Time frame: Up to 2 years after start of study treatment

  4. Biomarkers predictive of response and toxicity (protein profiling, HLA typing)

    Evaluation of biomarkers for prediction of response and toxicity

    Time frame: Up to 2 years after start of study treatment

08

Study locations

7 sites
  • Universitaetsklinikum Leipzig UCCL-Krebszentrum
    Leipzig, 04103, Germany
  • Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz-University Medical Center
    Mainz, 55131, Germany
  • Vall d'Hebron Institut Oncologia
    Barcelona, Spain
  • Hospital Universitario 12 De Octubre
    Madrid, Spain
  • University College London Hospitals NHS Foundation Trust - University College Hospital
    London, NW1 2PG, United Kingdom
  • The Christie NHS Foundation Trust
    Manchester, M20 4BX, United Kingdom
  • Nottingham University Hospitals NHS Trust - City Hospital
    Nottingham, NG5 1PB, United Kingdom
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2020 to primary completion in Apr 2023, 39 months.

Of 43 phase 2 interventional studies under Gallbladder Neoplasms, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 54. This study's 39 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 8, 2017
First posted
Aug 24, 2017
StartActual
Jan 7, 2020
Primary completionActual
Apr 27, 2023
CompletionActual
Aug 31, 2023
Last update
Nov 3, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 3, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03260712
Responsible party
Sponsor
First posted
Aug 24, 2017
Start date
Jan 7, 2020
Primary completion
Apr 27, 2023
Completion
Aug 31, 2023
Last update
Nov 3, 2023

Study contacts

Markus Moehler, Prof. Dr.
study chair · Johannes Gutenberg Universitaetskliniken - Mainz University Medical Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Studies of the drug tested here: Pembrolizumab

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