CClinicalTrials.gg
Sign In
CompletedNCT03111732Updated Dec 3, 2021Results posted

Pembrolizumab, a Monoclonal Antibody Against PD-1, in Combination With Capecitabine and Oxaliplatin (CAPOX) in People With Advanced Biliary Tract Carcinoma (BTC)

A Phase 2 interventional study of Pembrolizumab (MK-3475) and Oxaliplatin in Biliary Tract Neoplasms, Cholangiocarcinoma and Bile Duct Cancer, sponsored by National Cancer Institute (NCI). Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-12-03.

Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
11
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

Background:

Biliary tract cancers are rare but they are serious. Researchers want to see if a certain drug helps the immune system fight cancer cells. The drug is called pembrolizumab. It may work even better with two chemotherapy drugs that are widely used to treat gastrointestinal cancers.

Objective:

To study if pembrolizumab given with capecitabine and oxaliplatin (CAPOX) increases the time it takes for a person's biliary tract cancer to get worse.

Eligibility:

People age 18 and older with previously treated biliary tract cancer that has spread to other parts of the body

Design:

Participants will be screened with tests as part of their regular cancer care.

Each study cycle is 3 weeks.

For 6 cycles, participants will:

Get pembrolizumab and oxaliplatin on day 1 of each cycle. They will be given in an intravenous (IV) catheter.

Take capecitabine by mouth for 2 weeks then have 1 week without it.

Participants will complete a patient diary.

Starting with cycle 7, participants will get only pembrolizumab. They will get it once every 3 weeks.

On day 1 of every cycle, participants will have:

Physical exam

Review of symptoms and how well they do normal activities

Blood tests

Every 9 weeks, they will have a scan.

Participants may have tumor samples taken.

Participants will have a final visit about 1 month after they stop the study drug. After that, they will be contacted by phone or email yearly.

Read the detailed description

Background:

  • The most compelling argument in favor of testing immune-based strategies (and anti-Programmed cell death protein 1 (PD1) therapy in particular) in biliary tract cancers (BTC) is that chronic inflammation appears to be the most common etiologic factor in the development of biliary tract cancer.
  • Single-agent activity has been shown for PD1-directed therapy in BTC. Given the potential for oxaliplatin-induced immunogenic cell death we would like to evaluate the combination of capecitabine and oxaliplatin (CAPOX) chemotherapy with pembrolizumab.

Objective:

To determine the 5-month progression free survival (PFS) of Pembrolizumab in combination with CAPOX in patients with advanced biliary tract carcinoma.

Eligibility:

  • Histologically confirmed diagnosis biliary tract carcinoma OR histopathological confirmation of carcinoma in the setting of clinical and radiological characteristics which, together with the pathology, are highly suggestive of a diagnosis of biliary tract carcinoma.
  • Patients must have at least one prior chemotherapeutic regimen.
  • Patients must have disease that is not amenable to potentially curative resection.
  • No prior treatment with oxaliplatin.

Design:

The proposed study is a phase II study of Pembrolizumab in combination with CAPOX in patients with advanced biliary tract carcinoma

02

Conditions studied

  • Biliary Tract Neoplasms
  • Cholangiocarcinoma
  • Bile Duct Cancer
  • Liver Cancer
  • Gallbladder Cancer

Keywords

  • Immune-Based Strategies
  • Anti-PD1 Therapy
  • Chronic Inflammation
  • Combination Chemotherapy
03

In context

Cholangiocarcinoma

913 studies on the registry are indexed under Cholangiocarcinoma; 285 are open to participants now.

This study's enrollment of 11 is below the median of 50 across 686 interventional studies indexed under Cholangiocarcinoma.

Browse Cholangiocarcinoma studies →

Lead sponsor

National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.

Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Inclusion criteria

  • Patients must have histopathological confirmation of biliary tract carcinoma (BTC) by the Laboratory of Pathology of the National Cancer Institute (NCI) prior to entering this study OR histopathological confirmation of carcinoma in the setting of clinical and radiological characteristics which, together with the pathology, are highly suggestive of a diagnosis of biliary tract carcinoma. The term BTC includes intra- or extrahepatic cholangiocarcinoma, gallbladder cancer or ampullary cancer.
  • Patients must have disease that is not amenable to potentially curative resection. Patients must have received, been intolerant of or refused at least one line of chemotherapy.
  • Patients must have at least one focus of measurable metastatic disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
  • Patients must have at least one focus of metastatic disease that is amenable to pre- and on-treatment biopsies. Ideally the biopsied lesion should not be one of the target measurable lesions, although this can be up to the discretion of the investigators.
  • Age greater than or equal to 18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1

  • Patients must have normal organ and marrow function as defined below:

    • leukocytes greater than or equal to 3,000/mcL
    • absolute neutrophil count greater than or equal to 1,000/mcL
    • platelets greater than or equal to 100,000/mcL
    • total bilirubin less than or equal to 2 xULN
    • Serum albumin greater than or equal to 2.5g/dl
    • Patients are eligible with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) up to 5 x upper limit of normal (ULN).
    • creatinine \<1.5X institution upper limit of normal OR creatinine clearance greater than or equal to 45 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal
  • Patients must have recovered from any acute toxicity related to prior therapy, including surgery. Toxicity should be less than or equal to grade 1 or returned to baseline.
  • Patients must not have other invasive malignancies within the past 5 years (with the exception of non-melanoma skin cancers, non-invasive bladder cancer or localized prostate cancer for whom systemic therapy is not required).
  • Patient must be able to understand and willing to sign a written informed consent document.
  • The effects of Pembrolizumab in combination with Capecitabine and Oxaliplatin on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and up to 120 days after the last dose of the drug. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.

Exclusion criteria

EXCLUSION CRITERIA:

  • Patients who have had standard of care chemotherapy, large field radiotherapy, or major surgery must wait 2 weeks prior to entering the study.
  • Previous treatment with immune checkpoint inhibitors.
  • Patients who have undergone prior liver transplantation are ineligible.
  • Patients with known brain metastases will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active systemic infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia (excluding insignificant sinus bradycardia and sinus tachycardia) or psychiatric illness/social situations that would limit compliance with study requirements.
  • History of (non-infectious) pneumonitis that required steroids, evidence of interstitial lung disease or active, non-infectious pneumonitis.
  • History of chronic autoimmune disease (e.g., Addison s disease, multiple sclerosis, Graves disease, Hashimoto's thyroiditis, rheumatoid arthritis, hypophysitis, etc.) with symptomatic disease within the 3 years before randomization. Note: Active vitiligo or a history of vitiligo will not be a basis for exclusion.
  • Dementia or significantly altered mental status that would prohibit the understanding or rendering of Information and Consent and compliance with the requirements of the protocol
  • Active or history of inflammatory bowel disease (colitis, Crohn's), irritable bowel disease, celiac disease, or other serious, chronic, gastrointestinal conditions associated with diarrhea. Active or history of systemic lupus erythematosus or Wegener's granulomatosis.
  • Currently receiving immunosuppressive doses of steroids or other immunosuppressive medications (inhaled and topical steroids are permitted)
  • History of sarcoidosis syndrome.
  • Known history of active tuberculosis.
  • Patients should not be vaccinated with live attenuated vaccines within 1 month of starting pembrolizumab treatment.
  • Active hepatitis B or C infection.
  • Human Immunodeficiency Virus (HIV)-positive patients receiving anti-retroviral therapy are excluded from this study due to the possibility of pharmacokinetic interactions between antiretroviral medications and pembrolizumab. HIV positive patients not receiving antiretroviral therapy are excluded due to the possibility that pembrolizumab may worsen their condition and the likelihood that the underlying condition may obscure the attribution of adverse events.
  • History of hypersensitivity reaction to human or mouse antibody products.
  • Female patients who are pregnant or breastfeeding. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with Pembrolizumab in combination with Capecitabine and Oxaliplatin, breastfeeding should be discontinued.
  • Patients with unhealed surgical wounds for more than 30 days.
  • Prior therapy with oxaliplatin
05

Study design

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

Study arms

  • Experimental
    1/Arm 1

    Pembrolizumab plus Oxaliplatin plus Capecitabine

    Biological: Pembrolizumab (MK-3475) · Drug: Oxaliplatin · Drug: Capecitabine

Interventions

  • BiologicalPembrolizumab (MK-3475)

    200 mg will be administered as an IV infusion on Day 1 of each 21 day cycle

  • DrugOxaliplatin

    130mg/m(2) IV Infusion will be administered as an IV infusion on Day 1 of cycles 1-6

  • DrugCapecitabine

    750 mg/m(2) will be administered orally twice a day on Days 1-14 of cycles 1-6

06

What researchers measure

Primary outcomes

  1. Progression Free Survival (PFS)

    Median amount of time subject survives without disease progression for 5 months after treatment. Disease progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The appearance of one or more new lesions is also considered progressions.

    Time frame: 5 Months

Secondary outcomes

  1. Number of Participants Obtaining a Complete Response (CR) and Partial Response (PR)

    Number of participants obtaining CR and PR per the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria of all evaluable patients. CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR is at least a 30% decrease in the sum of the diameters of target lesions,taking as reference the baseline sum of diameters.

    Time frame: Every 9 Weeks, until disease progression or patient is taken off the trial, whichever comes first, approximately 36 weeks.

  2. Overall Survival

    Median amount of time subject survives after therapy.

    Time frame: Death, approximately 48 weeks after stopping therapy.

  3. Number Participants With Grade 1-4 Adverse Events Unrelated, Unlikely, Possibly, Probably and Definitely Related to Pembrolizumab

    Here is the number of participants with grade 1-4 adverse events unrelated, unlikely, possibly, probably and definitely related to study drug assessed by the Common Terminology Criteria for Adverse Events v4.0. Mild (Grade1), moderate (Grade 2), severe (Grade 3), and life-threatening or disabling (Grade 4).

    Time frame: 30 Days After Enrollment

  4. Number Participants With Grade 1-4 Adverse Events Unrelated, Unlikely, Possibly, Probably and Definitely Related to Oxaliplatin

    Here is the number of participants with grade 1-4 adverse events unrelated, unlikely, possibly, probably and definitely related to study drug assessed by the Common Terminology Criteria for Adverse Events v4.0. Mild (Grade1), moderate (Grade 2), severe (Grade 3), and life-threatening or disabling (Grade 4).

    Time frame: 30 Days After Enrollment

  5. Number of Participants With Grade 1-4 Adverse Events Unrelated, Unlikely, Possibly, and Probably Related to Capecitabine

    Here is the number of participants with grade 1-4 adverse events unrelated, unlikely, possibly, and probably related to study drug assessed by the Common Terminology Criteria for Adverse Events v4.0. Mild (Grade1), moderate (Grade 2), severe (Grade 3), and life-threatening or disabling (Grade 4).

    Time frame: 30 Days After Enrollment

Other outcomes

  1. Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)

    Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

    Time frame: Date treatment consent signed to date off study, approximately 38 months and 25 days.

07

Results

Posted Apr 15, 2021

Participant flow

Participant flow — Overall Study
Milestone1/Arm 1 - Pembrolizumab Plus Oxaliplatin Plus Capecitabine
Started11
Completed6
Not completed5
Withdrew: Enrolled in different study1
Withdrew: Progressive disease3
Withdrew: Withdrawal by subject1

Outcome measures

PrimaryProgression Free Survival (PFS)

Median amount of time subject survives without disease progression for 5 months after treatment. Disease progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The appearance of one or more new lesions is also considered progressions.

Time frame:
5 Months
Reported as:
Median · Months
Progression Free Survival (PFS)
Months1/Arm 1 - Pembrolizumab Plus Oxaliplatin Plus Capecitabine
Progression Free Survival (PFS)4.54 (2.5 to 9.6)
SecondaryNumber of Participants Obtaining a Complete Response (CR) and Partial Response (PR)

Number of participants obtaining CR and PR per the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria of all evaluable patients. CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR is at least a 30% decrease in the sum of the diameters of target lesions,taking as reference the baseline sum of diameters.

Time frame:
Every 9 Weeks, until disease progression or patient is taken off the trial, whichever comes first, approximately 36 weeks.
Reported as:
Count of participants · Participants
Number of Participants Obtaining a Complete Response (CR) and Partial Response (PR)
Participants1/Arm 1 - Pembrolizumab Plus Oxaliplatin Plus Capecitabine
Complete Response0
Partial Response3
SecondaryOverall Survival

Median amount of time subject survives after therapy.

Time frame:
Death, approximately 48 weeks after stopping therapy.
Reported as:
Median · Weeks
Overall Survival
Weeks1/Arm 1 - Pembrolizumab Plus Oxaliplatin Plus Capecitabine
Overall Survival43 (22 to 66)
SecondaryNumber Participants With Grade 1-4 Adverse Events Unrelated, Unlikely, Possibly, Probably and Definitely Related to Pembrolizumab

Here is the number of participants with grade 1-4 adverse events unrelated, unlikely, possibly, probably and definitely related to study drug assessed by the Common Terminology Criteria for Adverse Events v4.0. Mild (Grade1), moderate (Grade 2), severe (Grade 3), and life-threatening or disabling (Grade 4).

Time frame:
30 Days After Enrollment
Reported as:
Count of participants · Participants
Number Participants With Grade 1-4 Adverse Events Unrelated, Unlikely, Possibly, Probably and Definitely Related to Pembrolizumab
ParticipantsUnrelatedUnlikelyPossiblyProbablyDefinitely
Grade 19111030
Grade 2710830
Grade 337810
Grade 403200
SecondaryNumber Participants With Grade 1-4 Adverse Events Unrelated, Unlikely, Possibly, Probably and Definitely Related to Oxaliplatin

Here is the number of participants with grade 1-4 adverse events unrelated, unlikely, possibly, probably and definitely related to study drug assessed by the Common Terminology Criteria for Adverse Events v4.0. Mild (Grade1), moderate (Grade 2), severe (Grade 3), and life-threatening or disabling (Grade 4).

Time frame:
30 Days After Enrollment
Reported as:
Count of participants · Participants
Number Participants With Grade 1-4 Adverse Events Unrelated, Unlikely, Possibly, Probably and Definitely Related to Oxaliplatin
ParticipantsUnrelatedUnlikelyPossiblyProbablyDefinitely
Grade 19111174
Grade 2610952
Grade 336820
Grade 402210
SecondaryNumber of Participants With Grade 1-4 Adverse Events Unrelated, Unlikely, Possibly, and Probably Related to Capecitabine

Here is the number of participants with grade 1-4 adverse events unrelated, unlikely, possibly, and probably related to study drug assessed by the Common Terminology Criteria for Adverse Events v4.0. Mild (Grade1), moderate (Grade 2), severe (Grade 3), and life-threatening or disabling (Grade 4).

Time frame:
30 Days After Enrollment
Reported as:
Count of participants · Participants
Number of Participants With Grade 1-4 Adverse Events Unrelated, Unlikely, Possibly, and Probably Related to Capecitabine
ParticipantsUnrelatedUnlikelyPossiblyProbablyDefinitely
Grade 19111160
Grade 279940
Grade 336720
Grade 402210
Other pre-specifiedNumber of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)

Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

Time frame:
Date treatment consent signed to date off study, approximately 38 months and 25 days.
Reported as:
Count of participants · Participants
Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)
Participants1/Arm 1 - Pembrolizumab Plus Oxaliplatin Plus Capecitabine
Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)11

Adverse events

Collected over Date treatment consent signed to date off study, approximately 38 months and 25 days.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
1/Arm 1 - Pembrolizumab Plus Oxaliplatin Plus Capecitabine9/11 (81.8%)4/11 (36.4%)11/11 (100%)
Most frequent serious events
Most frequent serious events
Event1/Arm 1 - Pembrolizumab Plus Oxaliplatin Plus Capecitabine
DiarrheaGastrointestinal disorders2/11
Abdominal distensionGastrointestinal disorders1/11
AscitesGastrointestinal disorders1/11
BloatingGastrointestinal disorders1/11
ColitisGastrointestinal disorders1/11
Infections and infestations - Other, unknown originInfections and infestations1/11
Urinary tract infectionInfections and infestations1/11
Most frequent other events
Showing 10 of 92
Most frequent other events
Event1/Arm 1 - Pembrolizumab Plus Oxaliplatin Plus Capecitabine
Lymphocyte count decreasedInvestigations11/11
Alanine aminotransferase increasedInvestigations9/11
Aspartate aminotransferase increasedInvestigations9/11
Peripheral sensory neuropathyNervous system disorders9/11
Platelet count decreasedInvestigations9/11
AnemiaBlood and lymphatic system disorders8/11
HypoalbuminemiaMetabolism and nutrition disorders8/11
White blood cell decreasedInvestigations8/11
Alkaline phosphatase increasedInvestigations7/11
Abdominal painGastrointestinal disorders6/11

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)1/Arm 1 - Pembrolizumab Plus Oxaliplatin Plus Capecitabine
<=18 years0
Between 18 and 65 years6
>=65 years5
Age, Continuous
Age, Continuous(years)1/Arm 1 - Pembrolizumab Plus Oxaliplatin Plus Capecitabine
Mean64.32 ± 8.87
Sex: Female, Male
Sex: Female, Male(Participants)1/Arm 1 - Pembrolizumab Plus Oxaliplatin Plus Capecitabine
Female5
Male6
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)1/Arm 1 - Pembrolizumab Plus Oxaliplatin Plus Capecitabine
Hispanic or Latino1
Not Hispanic or Latino10
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)1/Arm 1 - Pembrolizumab Plus Oxaliplatin Plus Capecitabine
American Indian or Alaska Native0
Asian1
Native Hawaiian or Other Pacific Islander1
Black or African American0
White8
More than one race0
Unknown or Not Reported1
Region of Enrollment
Region of Enrollment(participants)1/Arm 1 - Pembrolizumab Plus Oxaliplatin Plus Capecitabine
United States11
08

Study locations

1 site
  • National Institutes of Health Clinical Center
    Bethesda, Maryland 20892, United States
09

References and documents

Publications

  • Rizvi NA, Hellmann MD, Snyder A, Kvistborg P, Makarov V, Havel JJ, Lee W, Yuan J, Wong P, Ho TS, Miller ML, Rekhtman N, Moreira AL, Ibrahim F, Bruggeman C, Gasmi B, Zappasodi R, Maeda Y, Sander C, Garon EB, Merghoub T, Wolchok JD, Schumacher TN, Chan TA. Cancer immunology. Mutational landscape determines sensitivity to PD-1 blockade in non-small cell lung cancer. Science. 2015 Apr 3;348(6230):124-8. doi: 10.1126/science.aaa1348. Epub 2015 Mar 12. PubMed 25765070 ↗
  • Topalian SL, Hodi FS, Brahmer JR, Gettinger SN, Smith DC, McDermott DF, Powderly JD, Carvajal RD, Sosman JA, Atkins MB, Leming PD, Spigel DR, Antonia SJ, Horn L, Drake CG, Pardoll DM, Chen L, Sharfman WH, Anders RA, Taube JM, McMiller TL, Xu H, Korman AJ, Jure-Kunkel M, Agrawal S, McDonald D, Kollia GD, Gupta A, Wigginton JM, Sznol M. Safety, activity, and immune correlates of anti-PD-1 antibody in cancer. N Engl J Med. 2012 Jun 28;366(26):2443-54. doi: 10.1056/NEJMoa1200690. Epub 2012 Jun 2. PubMed 22658127 ↗
  • Lamarca A, Hubner RA, David Ryder W, Valle JW. Second-line chemotherapy in advanced biliary cancer: a systematic review. Ann Oncol. 2014 Dec;25(12):2328-2338. doi: 10.1093/annonc/mdu162. Epub 2014 Apr 25. PubMed 24769639 ↗
  • Monge C, Pehrsson EC, Xie C, Duffy AG, Mabry D, Wood BJ, Kleiner DE, Steinberg SM, Figg WD, Redd B, Budhu A, Wang S, Tandon M, Ma L, Wei Wang X, Greten TF. A Phase II Study of Pembrolizumab in Combination with Capecitabine and Oxaliplatin with Molecular Profiling in Patients with Advanced Biliary Tract Carcinoma. Oncologist. 2022 Mar 11;27(3):e273-e285. doi: 10.1093/oncolo/oyab073. PubMed 35274717 ↗

Study documents

  • Protocol and statistical analysis plan · Mar 19, 2020
  • Informed consent form · Mar 19, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 3, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03111732
Lead sponsor
National Cancer Institute (NCI)
Responsible party
Tim Greten, M.D. (National Cancer Institute, National Cancer Institute (NCI)) — Principal investigator
First posted
Apr 13, 2017
Start date
Jun 14, 2017
Primary completion
Jul 22, 2020
Completion
Nov 8, 2021
Results posted
Apr 15, 2021
Last update
Dec 3, 2021

Study contacts

Tim F Greten, M.D.
principal investigator · National Cancer Institute (NCI)

Oversight

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

Not currently enrolling

This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

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.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Cholangiocarcinoma→

Other studies from this sponsor

National Cancer Institute (NCI)

Start the discussion