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CompletedNCT01473940Updated Mar 6, 2020Results posted

Ipilimumab and Gemcitabine Hydrochloride in Treating Patients With Stage III-IV or Recurrent Pancreatic Cancer That Cannot Be Removed by Surgery

A Phase 1 interventional study of ipilimumab and gemcitabine hydrochloride in Duct Cell Adenocarcinoma of the Pancreas, Recurrent Pancreatic Cancer and Stage III Pancreatic Cancer, sponsored by Northwestern University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-06.

Sponsored by Northwestern University · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
21
Ages
18 Years and older
Sex
All
01

Study summary

This phase I trial studies the side effects and best dose of ipilimumab when given together with gemcitabine hydrochloride in treating patients with stage III-IV or recurrent pancreatic cancer that cannot be removed by surgery. Monoclonal antibodies, such as ipilimumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or tumor-killing substances to them. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to kill tumor cells or stop them from growing. Giving monoclonal antibody therapy together with chemotherapy may kill more tumor cells.

Read the detailed description

OUTLINE: This is a dose-escalation study of ipilimumab.

INDUCTION: Patients receive ipilimumab intravenously (IV) over 90 minutes in weeks 1, 4, 7, and 10, and gemcitabine hydrochloride IV over 30 minutes in weeks 1-7 and 9-11.

MAINTENANCE: Beginning in week 22, patients receive ipilimumab IV over 90 minutes once every 12 weeks and gemcitabine hydrochloride IV over 30 minutes once weekly for 3 weeks. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Treatment modifications may apply according to response.

After completion of study treatment, patients are followed up monthly for 6 months and then every 3 months.

02

Conditions studied

  • Duct Cell Adenocarcinoma of the Pancreas
  • Recurrent Pancreatic Cancer
  • Stage III Pancreatic Cancer
  • Stage IV Pancreatic Cancer
03

In context

Pancreatic Neoplasms

3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.

This study's enrollment of 21 is below the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.

Browse Pancreatic Neoplasms studies →

Lead sponsor

Northwestern University is the lead sponsor of 1,396 studies on the registry; 199 are open to participants now.

Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) 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

  • Willing and able to give written informed consent
  • Histologic or cytologic diagnosis of pancreas adenocarcinoma advanced or recurrent (stage III or IV) that is unresectable; histologic or cytologic pathology from any prior surgery is sufficient for diagnosis
  • Must have measurable disease by modified WHO criteria
  • White blood cells (WBC) >= 2000/uL
  • Absolute neutrophil count (ANC) >= 1500/uL
  • Platelets >= 100 x 10\^3/uL
  • Hemoglobin >= 9 g/dL (>= 80 g/L; may be transfused)
  • Creatinine =\< 2.0 x upper limit of normal (ULN)
  • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 2.5 x ULN
  • Bilirubin =\< 2.0 x ULN, (except patients with Gilbert's Syndrome, who must have a total bilirubin less than 3.0 mg/dL)
  • No active or chronic infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
  • Performance status: Eastern Cooperative Oncology Group (ECOG) 0-1
  • Prior systemic therapy for advanced pancreas cancer with gemcitabine is prohibited; prior gemcitabine with radiotherapy for localized pancreas cancer is allowed provided disease is present outside of the radiated field; prior gemcitabine as adjuvant therapy to surgical resection is allowed provided 3 months or greater has elapsed between the last dose of gemcitabine and the detection of recurrent disease
  • Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 26 weeks after the last dose of investigational product, in such a manner that the risk of pregnancy is minimized; WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not post-menopausal; post-menopause is defined as: amenorrhea >= 12 consecutive months without another cause, or for women with irregular menstrual periods and taking hormone replacement therapy (HRT), a documented serum follicle stimulating hormone (FSH) level >= 35 mIU/mL; women who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing abstinence or where their partner is sterile (eg, vasectomy) should be considered to be of childbearing potential
  • WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotrophin [HCG]) within 72 hours before the start of ipilimumab
  • Men of fathering potential must be using an adequate method of contraception to avoid conception throughout the study (and for up to 26 weeks after the last dose of investigational product) in such a manner that the risk of pregnancy is minimized
  • Patients on stable anticoagulation are eligible for enrollment; for patients on warfarin, prothrombin time (PT)/international normalized ratio (INR) should be monitored every 2 weeks during induction therapy, monthly thereafter, or more frequent as clinically indicated

Exclusion criteria

Exclusion Criteria:

  • Any other malignancy from which the patient has been disease-free for less than 5 years, with the exception of adequately treated and cured basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix
  • Autoimmune disease: Patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn's Disease, are excluded from this study, as are patients with a history of symptomatic disease (eg, rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [eg, Wegener's Granulomatosis]); motor neuropathy considered of autoimmune origin (e.g. Guillain-Barre Syndrome and Myasthenia Gravis)
  • Any underlying medical or psychiatric condition, which in the opinion of the investigator will make the administration of ipilimumab hazardous or obscure the interpretation of adverse events (AEs), such as a condition associated with frequent diarrhea
  • Any non-oncology vaccine therapy used for prevention of infectious diseases (for up to 1 month before or after any dose of ipilimumab)
  • A history of prior treatment with ipilimumab or prior tumor necrosis factor receptor superfamily, member 9 (CD137) agonist or cytotoxic T-lymphocyte-associated protein 4 (CTLA4) inhibitor or agonist
  • Concomitant therapy with any of the following: interleukin (IL)2, interferon, or other non-study immunotherapy regimens; immunosuppressive agents; other investigation therapies; or chronic use of systemic corticosteroids
  • WOCBP who are unwilling or unable to use an acceptable method of contraception to avoid pregnancy for their entire study period and for at least 8 weeks after cessation of study drug, or have a positive pregnancy test at baseline, or are pregnant or breastfeeding
  • Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (eg, infectious) illness
  • Patients with symptoms of partial or complete bowel obstruction and recent (within 6 month) history of fistula, intra-abdominal abscess or bowel perforation
  • Patients with a history or evidence of central nervous system (CNS) disease, including brain tumor, seizures not controlled with standard medical therapy or any brain metastases
  • Patients currently receiving radiation therapy or those having received radiation within 4 weeks of study entry
  • Patients with any known active infection or known history of tuberculosis
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
21 participants (actual)

Study arms

  • Experimental
    Treatment (monoclonal antibody, chemotherapy)

    INDUCTION: Patients receive ipilimumab IV over 90 minutes in weeks 1, 4, 7, and 10 and gemcitabine hydrochloride IV over 30 minutes in weeks 1-7 and 9-11. MAINTENANCE: Beginning in week 22, patients receive ipilimumab IV over 90 minutes once every 12 weeks and gemcitabine hydrochloride IV over 30 minutes once weekly for 3 weeks. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Treatment modifications may apply according to response.

    Biological: ipilimumab · Drug: gemcitabine hydrochloride · Other: laboratory biomarker analysis

Interventions

  • Biologicalipilimumab

    Given IV

    Also known as: anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody, MDX-010, MDX-CTLA-4, monoclonal antibody CTLA-4

  • Druggemcitabine hydrochloride

    Given IV

    Also known as: dFdC, difluorodeoxycytidine hydrochloride, gemcitabine, Gemzar

  • Otherlaboratory biomarker analysis

    Correlative studies

06

What researchers measure

Primary outcomes

  1. Number of Dose Limiting Toxicities (DLTs) Seen in Patients With Pancreas Adenocarcinoma Treated With Ipilimumab and Gemcitabine Combination in Order to Define the Maximum Tolerated Dose (MTD)

    Dose limiting toxicity (DLT) will be monitored by calculating the Bayesian predictive probability of a DLT given the data to date. All toxicities will be summarized in a descriptive manner as to type, frequency, attribution and timing by dose level. Safety will be evaluated for all treated patients using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 where grading is as follows: Mild (grade 1) Moderate (grade 2) Severe (grade 3) Life-threatening (grade 4) Fatal (grade 5) In general a DLT will be defined as any any of the following drug-related toxicities: Febrile neutropenia with grade 3/4 neutropenia Asymptomatic grade 4 neutropenia more than 7 days Grade 3 thrombocytopenia with grade 3-4 hemorrhage or grade 4 thrombocytopenia Non-hematologic toxicity grade 3 or 4 (with some protocol specified exceptions) DLTs will be used to determine the MTD for the expansion cohort of the study. \*AST = Aspartate transamina

    Time frame: During the 12 weeks of Induction Therapy

Secondary outcomes

  1. Response Rate Using Immune-related Response Criteria (irRC) in Patients With Pancreas Adenocarcinoma Treated With Ipilimumab and Gemcitabine Combination

    Response will be assessed using CT of MRI scans immune-related response criteria (irRC). The sum of all the products of diameters (SPD) at tumor assessment using the irRC for progressive disease incorporates the contribution of new measurable lesions. Each net percentage change in tumor burden per assessment using irRC accounts for the size and growth kinetics of both old and new lesions as they appear. irComplete Response (irCR)-Complete disappearance of all index lesions. irPartial Response (irPR)-Decrease of 50% or greater in the sum of products of the two largest perpendicular diameters of all index and all new measurable lesions (i.e., percentage change in tumor burden) irStable Disease (irSD)-does not meet criteria for irCR or ir PR, in the absence of progressive disease. irProgressive Disease (irPD)-At least 25% increase in the percentage change in tumor burden (i.e., taking sum of all the products of all the index lesions and any new lesions) when compared to SPD at nadir.

    Time frame: Every 12 weeks during treatment with a 12 week induction and then 28 day maintenance cycles. Range of cycles completed (including induction cycle) 0-10

  2. Time to Progression Patients With Pancreas Adenocarcinoma Treated With Ipilimumab and Gemcitabine Combination Who Progress While on Treatment

    Time to Progression will be defined as the time from treatment initiation until the first documentation of progression as calculated by irRC in patients who show progression. Progression will be defined as at least a 25% increase percentage change in tumor burden (i.e., taking the sum of all the products of all index lesions and any new lesions) when compared to sum of all the products of diameters (SPD) at nadir.

    Time frame: Every 12 weeks during treatment with a 12 week induction and then 28 day maintenance cycles. Range of cycles completed (including induction cycle) 0-10

  3. Progression Free Survival (PFS) in Patients With Pancreas Adenocarcinoma Treated With Ipilimumab and Gemcitabine Combination

    Median Progression Free Survival (mPFS) was estimated using a Kaplan-Meier curve with 0 censored patients. PFS is defined from the time of treatment initiation until the first documentation of progressive disease. Any patient without the event at the time of analysis will be censored from the last documented contact.

    Time frame: Every 12 weeks during treatment with a 12 week induction and then 28 day maintenance cycles. Range of cycles completed (including induction cycle) 0-10

  4. Overall Survival (OS) in Patients With Pancreas Adenocarcinoma Treated With Ipilimumab and Gemcitabine Combination

    Overall Survival (OS) was estimated using a kaplan-meier curve with 0 patients censored. OS is defined from the time of treatment initiation until the time of death from any cause. Any patient without the event at the time of analysis will be censored from the last documented contact.

    Time frame: Every 12 weeks during treatment with a 12 week induction and then 28 day maintenance cycles. Range of cycles completed (including induction cycle) 0-10

  5. Recovery of Tumor Immune Surveillance: T-cell Response to Defined Pancreatic Cancer Tumor Antigens

    Optional blood draws to analyze the inflammatory T cell function before, during and after treatment.

    Time frame: Prior to ipilimumab infusion at weeks 1, 4, 7, and 10, and then every 12 weeks starting at week 13 where range of cycles including induction cycle was 0-10 (Induction cycle = 12 weeks, maintenance cycle = 28 days)

07

Results

Posted Mar 6, 2020

Participant flow

The study opened at our site April 3, 2012 with the first patient being enrolled and starting treatment on June 11, 2012. The study was designed to with 4 dose escalation cohorts to determine maximum tolerated dose (MTD) and then an expansion cohort at the MTD. The study closed March 23, 2016 with a total of 21 patients treated on the study.

Induction Therapy
Participant flow — Induction Therapy
MilestoneCohort 1 Gemcitabine - 750 mg/m2, Ipilimumab 3 mg/kgCohort 2 Gemcitabine - 1,000 mg/m2, Ipilimumab 3 mg/kgCohort 3 Gemcitabine -1,000 mg/m2, Ipilimumab 6 mg/kgExpansion Cohort Gemcitabine - 1,000 mg/m2, Ipilimumab 3 mg/kg
Started3468
Started treatment3468
Completed induction- 12 weeks3347
Completed3347
Not completed0121
Withdrew: Death0011
Withdrew: Progressive disease0110
Maintenance Therapy
Participant flow — Maintenance Therapy
MilestoneCohort 1 Gemcitabine - 750 mg/m2, Ipilimumab 3 mg/kgCohort 2 Gemcitabine - 1,000 mg/m2, Ipilimumab 3 mg/kgCohort 3 Gemcitabine -1,000 mg/m2, Ipilimumab 6 mg/kgExpansion Cohort Gemcitabine - 1,000 mg/m2, Ipilimumab 3 mg/kg
Started3347
Evaluated for response3347
Went on to start maintenance therapy2133
Completed2133
Not completed1214
Withdrew: Progressive disease1214
Follow-up Until Death
Participant flow — Follow-up Until Death
MilestoneCohort 1 Gemcitabine - 750 mg/m2, Ipilimumab 3 mg/kgCohort 2 Gemcitabine - 1,000 mg/m2, Ipilimumab 3 mg/kgCohort 3 Gemcitabine -1,000 mg/m2, Ipilimumab 6 mg/kgExpansion Cohort Gemcitabine - 1,000 mg/m2, Ipilimumab 3 mg/kg
Started3457
Completed3457
Not completed0000

Outcome measures

PrimaryNumber of Dose Limiting Toxicities (DLTs) Seen in Patients With Pancreas Adenocarcinoma Treated With Ipilimumab and Gemcitabine Combination in Order to Define the Maximum Tolerated Dose (MTD)

Dose limiting toxicity (DLT) will be monitored by calculating the Bayesian predictive probability of a DLT given the data to date. All toxicities will be summarized in a descriptive manner as to type, frequency, attribution and timing by dose level. Safety will be evaluated for all treated patients using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 where grading is as follows: Mild (grade 1) Moderate (grade 2) Severe (grade 3) Life-threatening (grade 4) Fatal (grade 5) In general a DLT will be defined as any any of the following drug-related toxicities: Febrile neutropenia with grade 3/4 neutropenia Asymptomatic grade 4 neutropenia more than 7 days Grade 3 thrombocytopenia with grade 3-4 hemorrhage or grade 4 thrombocytopenia Non-hematologic toxicity grade 3 or 4 (with some protocol specified exceptions) DLTs will be used to determine the MTD for the expansion cohort of the study. \*AST = Aspartate transamina

Time frame:
During the 12 weeks of Induction Therapy
Reported as:
Number · DLTs
Number of Dose Limiting Toxicities (DLTs) Seen in Patients With Pancreas Adenocarcinoma Treated With Ipilimumab and Gemcitabine Combination in Order to Define the Maximum Tolerated Dose (MTD)
DLTsCohort 1 Gemcitabine - 750 mg/m2, Ipilimumab 3 mg/kgCohort 2 Gemcitabine - 1,000 mg/m2, Ipilimumab 3 mg/kgCohort 3 Gemcitabine -1,000 mg/m2, Ipilimumab 6 mg/kg
Number of DLTS seen in cohort002
Number of AST increase DLTs seen in cohort001
Number of diarrhea DLTs seen in cohort001
Statistical analysis
  • Cohort 1 Gemcitabine - 750 mg/m2, Ipilimumab 3 mg/kg vs Cohort 2 Gemcitabine - 1,000 mg/m2, Ipilimumab 3 mg/kg vs Cohort 3 Gemcitabine -1,000 mg/m2, Ipilimumab 6 mg/kg ·
SecondaryResponse Rate Using Immune-related Response Criteria (irRC) in Patients With Pancreas Adenocarcinoma Treated With Ipilimumab and Gemcitabine Combination

Response will be assessed using CT of MRI scans immune-related response criteria (irRC). The sum of all the products of diameters (SPD) at tumor assessment using the irRC for progressive disease incorporates the contribution of new measurable lesions. Each net percentage change in tumor burden per assessment using irRC accounts for the size and growth kinetics of both old and new lesions as they appear. irComplete Response (irCR)-Complete disappearance of all index lesions. irPartial Response (irPR)-Decrease of 50% or greater in the sum of products of the two largest perpendicular diameters of all index and all new measurable lesions (i.e., percentage change in tumor burden) irStable Disease (irSD)-does not meet criteria for irCR or ir PR, in the absence of progressive disease. irProgressive Disease (irPD)-At least 25% increase in the percentage change in tumor burden (i.e., taking sum of all the products of all the index lesions and any new lesions) when compared to SPD at nadir.

Time frame:
Every 12 weeks during treatment with a 12 week induction and then 28 day maintenance cycles. Range of cycles completed (including induction cycle) 0-10
Reported as:
Count of participants · Participants
Response Rate Using Immune-related Response Criteria (irRC) in Patients With Pancreas Adenocarcinoma Treated With Ipilimumab and Gemcitabine Combination
ParticipantsCohort 1 Gemcitabine - 750 mg/m2, Ipilimumab 3 mg/kgCohort 2 Gemcitabine - 1,000 mg/m2, Ipilimumab 3 mg/kgCohort 3 Gemcitabine -1,000 mg/m2, Ipilimumab 6 mg/kgExpansion Cohort Gemcitabine - 1,000 mg/m2, Ipilimumab 3 mg/kg
irCR0000
irPR0111
irSD2032
irPD1313
NE - Death0012
SecondaryTime to Progression Patients With Pancreas Adenocarcinoma Treated With Ipilimumab and Gemcitabine Combination Who Progress While on Treatment

Time to Progression will be defined as the time from treatment initiation until the first documentation of progression as calculated by irRC in patients who show progression. Progression will be defined as at least a 25% increase percentage change in tumor burden (i.e., taking the sum of all the products of all index lesions and any new lesions) when compared to sum of all the products of diameters (SPD) at nadir.

Time frame:
Every 12 weeks during treatment with a 12 week induction and then 28 day maintenance cycles. Range of cycles completed (including induction cycle) 0-10

No measurements were reported for this outcome.

SecondaryProgression Free Survival (PFS) in Patients With Pancreas Adenocarcinoma Treated With Ipilimumab and Gemcitabine Combination

Median Progression Free Survival (mPFS) was estimated using a Kaplan-Meier curve with 0 censored patients. PFS is defined from the time of treatment initiation until the first documentation of progressive disease. Any patient without the event at the time of analysis will be censored from the last documented contact.

Time frame:
Every 12 weeks during treatment with a 12 week induction and then 28 day maintenance cycles. Range of cycles completed (including induction cycle) 0-10
Reported as:
Median · months
Progression Free Survival (PFS) in Patients With Pancreas Adenocarcinoma Treated With Ipilimumab and Gemcitabine Combination
monthsCohort 1 Gemcitabine - 750 mg/m2, Ipilimumab 3 mg/kgCohort 2/Expansion Gemcitabine-1,000mg/m2+Ipilimumab-3mg/kgCohort 3 Gemcitabine -1,000 mg/m2, Ipilimumab 6 mg/kg
Progression Free Survival (PFS) in Patients With Pancreas Adenocarcinoma Treated With Ipilimumab and Gemcitabine Combination3.3859 (2.5970 to 8.0868)2.5312 (0.7890 to 4.8323)3.8626 (0.7561 to 22.4195)
SecondaryOverall Survival (OS) in Patients With Pancreas Adenocarcinoma Treated With Ipilimumab and Gemcitabine Combination

Overall Survival (OS) was estimated using a kaplan-meier curve with 0 patients censored. OS is defined from the time of treatment initiation until the time of death from any cause. Any patient without the event at the time of analysis will be censored from the last documented contact.

Time frame:
Every 12 weeks during treatment with a 12 week induction and then 28 day maintenance cycles. Range of cycles completed (including induction cycle) 0-10
Reported as:
Median · months
Overall Survival (OS) in Patients With Pancreas Adenocarcinoma Treated With Ipilimumab and Gemcitabine Combination
monthsCohort 1 Gemcitabine - 750 mg/m2, Ipilimumab 3 mg/kgCohort 2/Expansion Gemcitabine-1,000mg/m2+Ipilimumab-3mg/kgCohort 3 Gemcitabine -1,000 mg/m2, Ipilimumab 6 mg/kg
Overall Survival (OS) in Patients With Pancreas Adenocarcinoma Treated With Ipilimumab and Gemcitabine Combination5.3254 (5.0953 to 9.5661)5.7199 (1.6108 to 22.8139)8.9908 (0.7561 to 30.0460)
SecondaryRecovery of Tumor Immune Surveillance: T-cell Response to Defined Pancreatic Cancer Tumor Antigens

Optional blood draws to analyze the inflammatory T cell function before, during and after treatment.

Time frame:
Prior to ipilimumab infusion at weeks 1, 4, 7, and 10, and then every 12 weeks starting at week 13 where range of cycles including induction cycle was 0-10 (Induction cycle = 12 weeks, maintenance cycle = 28 days)

No measurements were reported for this outcome.

Post-hocDuration of Response in Patients Pancreas Adenocarcinoma Treated With Ipilimumab and Gemcitabine Combination

Duration of response is shown below for patients who showed a response as defined by immune-related response criteria (irCR) as either of the following: irComplete Response (irCR)-Complete disappearance of all index lesions or irPartial Response (irPR)-Decrease of 50% or greater in the sum of products of the two largest perpendicular diameters of all index and all new measurable lesions (i.e., percentage change in tumor burden) Duration of response is defined as the time from first documentation of response to first documentation of progression, with progression defined as: irProgressive Disease (irPD)-At least 25% increase in the percentage change in tumor burden (i.e., taking sum of all the products of all the index lesions and any new lesions) when compared to the sum of all the product diameters (SPD) at nadir.

Time frame:
From the time of response and every 12 weeks during treatment with a 12 week induction and then 28 day maintenance cycles. Range of cycles completed (including induction cycle) 0-10
Reported as:
Number · months
Duration of Response in Patients Pancreas Adenocarcinoma Treated With Ipilimumab and Gemcitabine Combination
monthsCohort 1 Gemcitabine - 750 mg/m2, Ipilimumab 3 mg/kgCohort 2 Gemcitabine-1,000mg/m2+Ipilimumab-3mg/kgCohort 3 Gemcitabine -1,000 mg/m2, Ipilimumab 6 mg/kgExpansion - Gemcitabine-1,000mg/m2+Ipilimumab-3mg/kg
Duration of Response in Patients Pancreas Adenocarcinoma Treated With Ipilimumab and Gemcitabine Combination—8.519.811

Adverse events

Collected over Adverse Events were collected from the time of treatment initiation until treatment discontinuation for any reason. Treatment was considered to be one induction cycle of 12 weeks followed by 28 day maintenance cycles with the range of cycles completed by any patients 0-10 (including the induction cycle). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Cohort 1 Gemcitabine - 750 mg/m2, Ipilimumab 3 mg/kg3/3 (100%)2/3 (66.7%)3/3 (100%)
Cohort 2 Gemcitabine - 1,000 mg/m2, Ipilimumab 3 mg/kg4/4 (100%)3/4 (75%)4/4 (100%)
Cohort 3 Gemcitabine -1,000 mg/m2, Ipilimumab 6 mg/kg6/6 (100%)4/6 (66.7%)6/6 (100%)
Expansion Cohort Gemcitabine - 1,000 mg/m2, Ipilimumab 3 mg/kg8/8 (100%)5/8 (62.5%)8/8 (100%)
Most frequent serious events
Showing 10 of 23
Most frequent serious events
EventCohort 1 Gemcitabine - 750 mg/m2, Ipilimumab 3 mg/kgCohort 2 Gemcitabine - 1,000 mg/m2, Ipilimumab 3 mg/kgCohort 3 Gemcitabine -1,000 mg/m2, Ipilimumab 6 mg/kgExpansion Cohort Gemcitabine - 1,000 mg/m2, Ipilimumab 3 mg/kg
Duodenal ObstructionGastrointestinal disorders1/30/40/60/8
VomitingGastrointestinal disorders1/30/40/60/8
Catheter-related InfectionInfections and infestations0/31/40/60/8
DiarrheaGastrointestinal disorders0/31/40/60/8
SepsisInfections and infestations0/31/40/60/8
VomitingGastrointestinal disorders0/30/41/60/8
AscitesGastrointestinal disorders0/30/41/60/8
Abdominal painGastrointestinal disorders0/30/41/60/8
Bilirubin IncreasedInvestigations0/30/41/60/8
Sepsis resulting in deathInfections and infestations0/30/41/60/8
Most frequent other events
Showing 10 of 106
Most frequent other events
EventCohort 1 Gemcitabine - 750 mg/m2, Ipilimumab 3 mg/kgCohort 2 Gemcitabine - 1,000 mg/m2, Ipilimumab 3 mg/kgCohort 3 Gemcitabine -1,000 mg/m2, Ipilimumab 6 mg/kgExpansion Cohort Gemcitabine - 1,000 mg/m2, Ipilimumab 3 mg/kg
AnemiaBlood and lymphatic system disorders2/34/46/67/8
ConstipationGastrointestinal disorders2/33/46/65/8
NauseaGastrointestinal disorders2/33/46/64/8
FatigueGeneral disorders3/32/46/66/8
Aspartate Aminotransferase IncreasedInvestigations2/33/46/66/8
Lymphocyte Count DecreasedInvestigations3/34/45/64/8
Platelet Count DecreasedInvestigations2/34/46/65/8
HyperglycemiaMetabolism and nutrition disorders2/33/46/66/8
HypoalbuminemiaMetabolism and nutrition disorders2/34/45/66/8
HypocalcemiaMetabolism and nutrition disorders1/34/44/63/8

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Cohort 1 Gemcitabine - 750 mg/m2, Ipilimumab 3 mg/kgCohort 2 Gemcitabine - 1,000 mg/m2, Ipilimumab 3 mg/kgCohort 3 Gemcitabine -1,000 mg/m2, Ipilimumab 6 mg/kgExpansion Cohort Gemcitabine - 1,000 mg/m2, Ipilimumab 3 mg/kgTotal
<=18 years00000
Between 18 and 65 years13329
>=65 years213612
Sex: Female, Male
Sex: Female, Male(Participants)Cohort 1 Gemcitabine - 750 mg/m2, Ipilimumab 3 mg/kgCohort 2 Gemcitabine - 1,000 mg/m2, Ipilimumab 3 mg/kgCohort 3 Gemcitabine -1,000 mg/m2, Ipilimumab 6 mg/kgExpansion Cohort Gemcitabine - 1,000 mg/m2, Ipilimumab 3 mg/kgTotal
Female234413
Male11248
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Cohort 1 Gemcitabine - 750 mg/m2, Ipilimumab 3 mg/kgCohort 2 Gemcitabine - 1,000 mg/m2, Ipilimumab 3 mg/kgCohort 3 Gemcitabine -1,000 mg/m2, Ipilimumab 6 mg/kgExpansion Cohort Gemcitabine - 1,000 mg/m2, Ipilimumab 3 mg/kgTotal
Hispanic or Latino00000
Not Hispanic or Latino346821
Unknown or Not Reported00000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Cohort 1 Gemcitabine - 750 mg/m2, Ipilimumab 3 mg/kgCohort 2 Gemcitabine - 1,000 mg/m2, Ipilimumab 3 mg/kgCohort 3 Gemcitabine -1,000 mg/m2, Ipilimumab 6 mg/kgExpansion Cohort Gemcitabine - 1,000 mg/m2, Ipilimumab 3 mg/kgTotal
American Indian or Alaska Native00000
Asian00000
Native Hawaiian or Other Pacific Islander00000
Black or African American00000
White345618
More than one race00000
Unknown or Not Reported00123
Region of Enrollment
Region of Enrollment(Participants)Cohort 1 Gemcitabine - 750 mg/m2, Ipilimumab 3 mg/kgCohort 2 Gemcitabine - 1,000 mg/m2, Ipilimumab 3 mg/kgCohort 3 Gemcitabine -1,000 mg/m2, Ipilimumab 6 mg/kgExpansion Cohort Gemcitabine - 1,000 mg/m2, Ipilimumab 3 mg/kgTotal
United States346821
08

Study locations

1 site
  • Northwestern University
    Chicago, Illinois 60611, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 6, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01473940
Lead sponsor
Northwestern University
Collaborators
Robert H. Lurie Cancer Center
Responsible party
Mary Mulcahy (Mary Mulcahy, MD, Northwestern University) — Principal investigator
First posted
Nov 17, 2011
Start date
Jun 11, 2012
Primary completion
Oct 16, 2014
Completion
May 6, 2018
Results posted
Mar 6, 2020
Last update
Mar 6, 2020

Study contacts

Mary Mulcahy
principal investigator · Northwestern University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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