ClinicalTrials.gg
TerminatedNCT01769222Updated Jan 24, 2024Results posted

Ipilimumab and Local Radiation for Selected Solid Tumors

A Phase 1 interventional study of Ipilimumab and Radiation therapy in Adult Nasal Type Extranodal NK/T-cell Lymphoma, Anaplastic Large Cell Lymphoma and Angioimmunoblastic T-cell Lymphoma, sponsored by Stanford University. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-24.

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

Why this study was terminated
Planned Future Study
Phase
Phase 1
Study type
Interventional
Enrollment
3
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 144 studies in Lymphoma, Extranodal NK-T-Cell with a site in United States — 5 open to participants now, 11 under way, none of them phase 3. Lymphoma, Extranodal NK-T-Cell · United States.

Enrollment
117th of 129
3 · median 26
Started
2013
with 4 others
Phase 1
55 of 144
1 open now
Registered
120th of 144
by date

Among the 144 studies in Lymphoma, Extranodal NK-T-Cell with a site in United States, this one is the 117th largest by enrollment of the 129 interventional ones that give a count, is one of 5 that started in 2013, is one of 55 in phase 1, and was the 120th registered.

Lymphoma, Extranodal NK-T-Cell

270 studies on the registry are indexed under Lymphoma, Extranodal NK-T-Cell; 36 are open to participants now.

Browse Lymphoma, Extranodal NK-T-Cell studies →

Open to participants now

5 of the 144 studies in Lymphoma, Extranodal NK-T-Cell with a site in United States are open now. Recruiting first, the newest first:

All 5 open studies →

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

Who these studies take

Of the 20 Lymphoma, Extranodal NK-T-Cell studies recruiting now, 11 (55%) set no upper age limit and 8 (40%) stop at 75 or younger; 4 take children under 18; 1 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 144 studies in Lymphoma, Extranodal NK-T-Cell with a site in United States, or all of them as a file.
02

Study summary

This pilot phase 1-2 trial studies the side effects and best of dose ipilimumab when given together with local radiation therapy and to see how well it works in treating patients with recurrent melanoma, non-Hodgkin lymphoma, colon, or rectal cancer. Monoclonal antibodies, such as ipilimumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Radiation therapy uses high energy x rays to kill cancer cells. Giving monoclonal antibody therapy together with radiation therapy may be an effective treatment for melanoma, non-Hodgkin lymphoma, colon, or rectal cancer.

  • The phase 1 component ("safety") of this study is ipilimumab 25 mg monotherapy.
  • The phase 2 component ("treatment-escalation") of this study is ipilimumab 25 mg plus radiation combination therapy.
Read the detailed description

PRIMARY OBJECTIVES:

  1. To assess the safety of combining intratumoral anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA4) immunotherapy with local radiation therapy in patients with melanoma, non-Hodgkin lymphoma, and colorectal carcinoma with a monotherapy ipilimumab safety lead-in.

SECONDARY OBJECTIVES:

  1. To assess the induction of an anti-tumor immune responses using laboratory correlative studies.
  2. To determine tumor response rates and duration of response at unirradiated tumor sites in patients with advanced malignancies.
  3. To identify putative immunologic biomarkers of tumor response.

OUTLINE: This is a phase I safety study of ipilimumab monotherapy, followed by a phase 2 study. Only a few subjects participated in the phase 1 portion of this study. The phase 2 treatment-escalation portion of this study (ipilimumab plus radiation combination therapy) was not conducted.

Patients receive ipilimumab intratumorally on day 1 and undergo local radiation therapy within 48 hours for at least 3 fractions.

After completion of study treatment, patients are followed up at 4 and 8 weeks, and then every 24 weeks for 5 years.

03

Conditions studied

  • Adult Nasal Type Extranodal NK/T-cell Lymphoma
  • Anaplastic Large Cell Lymphoma
  • Angioimmunoblastic T-cell Lymphoma
  • Cutaneous B-cell Non-Hodgkin Lymphoma
  • Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
  • Hepatosplenic T-cell Lymphoma
  • Intraocular Lymphoma
  • Nodal Marginal Zone B-cell Lymphoma
  • Peripheral T-cell Lymphoma
  • Recurrent Adult Burkitt Lymphoma
  • Recurrent Adult Diffuse Large Cell Lymphoma
  • Recurrent Adult Diffuse Mixed Cell Lymphoma
  • Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
  • Recurrent Adult Grade III Lymphomatoid Granulomatosis
  • Recurrent Adult Immunoblastic Large Cell Lymphoma
  • Recurrent Adult Lymphoblastic Lymphoma
  • Recurrent Adult T-cell Leukemia/Lymphoma
  • Recurrent Colon Cancer
  • Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
  • Recurrent Grade 1 Follicular Lymphoma
  • Recurrent Grade 2 Follicular Lymphoma
  • Recurrent Grade 3 Follicular Lymphoma
  • Recurrent Mantle Cell Lymphoma
  • Recurrent Marginal Zone Lymphoma
  • Recurrent Melanoma
  • Recurrent Mycosis Fungoides/Sezary Syndrome
  • Recurrent Rectal Cancer
  • Recurrent Small Lymphocytic Lymphoma
  • Refractory Hairy Cell Leukemia
  • Small Intestine Lymphoma
  • Splenic Marginal Zone Lymphoma
  • T-cell Large Granular Lymphocyte Leukemia
  • Testicular Lymphoma
  • Waldenström Macroglobulinemia
04

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

  • Willing and able to give written

    • Before any study procedures are performed, subjects (or their legally acceptable representatives) will have the details of the study described to them, and they will be given a written informed consent document to read; then, if subjects consent to participate in the study, they will indicate that consent by signing and dating the informed consent document in the presence of study personnel
  • confirmed

    • In Phase 1, histologically confirmed melanoma.
    • In Phase 2, histologically confirmed melanoma, non-Hodgkin lymphoma, or colorectal carcinoma
  • Must have failed at least 1 systemic therapy or be intolerant to at least one prior systemic treatment
  • Must have at least 2 lesions of evaluable size by modified World Health Organization (mWHO)/Cheson criteria; 1 of 2 lesions must be amenable to (core or fine needle aspirate) and intratumoral injection of up to 5 mL (diameter ≥ 10mm)
  • Subjects with asymptomatic are eligible; (systemic should be avoided if possible, or the subject should be stable on the lowest clinically effective dose, as steroids as they may interfere with the activity of ipilimumab if administered at the time of the first ipilimumab dose)
  • Must be at least 28 days since treatment with standard or chemotherapy, biochemotherapy, surgery, radiation, cytokine therapy, or immunotherapy, and recovered from any toxicity experienced during treatment
  • (ECOG) performance status of 0, 1, or 2
  • of ≥ 16 weeks
  • Subjects must have baseline (screening/baseline) radiographic images, (e.g. brain, chest, abdomen, pelvis, and bone scans with specific imaging tests to be determined by the attending physician) within 6 weeks of initiation of ipilimumab
  • White blood cell (WBC) ≥ 2000/uL (\~2 x 10\^9/L)
  • (ANC) ≥ 1000/uL (\~0.5 x 10\^9/L)
  • ≥ 75 x 10\^3/uL (\~75 x 10\^9/L)
  • ≥ 9 g/dL (may be transfused)
  • Creatinine ≤ 2.0 x (ULN)
  • (AST)/alanine aminotransferase (ALT) ≤ 2.5 x ULN for subjects without liver ≤ 5 times for liver metastases
  • ≤ 2.0 x ULN (except for subjects with Gilbert's syndrome, who must have a total bilirubin of less than 3.0 mg/dL)
  • No active or chronic infection with (HIV), , or
  • Women of (WOCBP) must be using an adequate method of 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-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 gonadotropin [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

Exclusion criteria

Exclusion Criteria:

  • Any other 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
  • 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
  • Patients with underlying heart conditions who are deemed ineligible for surgery by cardiology consult
  • 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 CD137 agonist or CTLA 4 inhibitor or agonist
  • Concomitant therapy with any of the following: interleukin-2 (IL 2), interferon, or other non-study immunotherapy regimens; cytotoxic chemotherapy; agents; other investigation therapies; or chronic use of systemic

    • A history of AEs with prior IL-2 or Interferon will not preclude subjects from entering the current study
  • Any agents
  • Immunosuppressive agents (unless required for treating potential AEs)
  • Chronic systemic corticosteroids (unless required for treating treatment emergent AEs or required for management of signs or symptoms due to , upon discussion with Bristol-Myers Squibb [BMS] medical monitor)
  • Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (eg, infectious) illness
  • Women of (WOCBP) who:

    • Are unwilling or unable to use an acceptable method of 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
  • Persons of must agree to use an adequate method of contraception throughout treatment and for at least 8 weeks after ipilimumab is stopped; sexually active WOCBP must use an effective method of birth control during the course of the study, in a manner such that risk of failure is minimized; before study enrollment, WOCBP must be advised of the importance of avoiding pregnancy during study participation and the potential risk factors for an unintentional pregnancy; all WOCBP MUST have a negative pregnancy test before first receiving ipilimumab; if the pregnancy test is positive, the patient must not receive ipilimumab and must not be enrolled in the study
Terms in these criteria, in plain language(26)

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.

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.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

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.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Brain metastases

Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).

Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.

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.

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.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

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.

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.

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).

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.

Metastases

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

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.

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.

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.

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.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

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.

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.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
3 participants (actual)

Study arms

  • Experimental
    Ipilimumab 25 mg (Phase 1)

    Participants receive ipilimumab intratumorally on Day 1

    Biological: Ipilimumab

  • Experimental
    Ipilimumab 25 mg and radiation therapy (Phase 2)

    Participants receive ipilimumab intratumorally on Day 1 and undergo local radiation therapy (10 Gy/fraction) within 48 hours for at least 3 fractions

    Biological: Ipilimumab · Radiation: Radiation therapy

Interventions

  • BiologicalIpilimumab

    Given intratumorally

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

  • RadiationRadiation therapy

    Undergo local radiation therapy, 10 Gy x 3 fractions

    Also known as: Irradiation, Radiotherapy, Therapy, radiation

06

What researchers measure

Primary outcomes

  1. Dose-limiting Toxicity

    Safety as the percentage of patients in Phase 1 (ipilimumab monotherapy) of the study, who experienced dose-limiting toxicities (DLTs) or serious adverse events (SAEs), using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

    Time frame: 4 weeks

Secondary outcomes

  1. Immune Response (Phase 2 Only)

    Data will be summarized using proportions with exact 95% confidence intervals, means, standard deviations, and ranges.

    Time frame: 4 weeks

  2. Immune Response (Phase 2 Only)

    Data will be summarized using proportions with exact 95% confidence intervals, means, standard deviations, and ranges.

    Time frame: 8 weeks

  3. Response Rate (Phase 2 Only)

    Response rates calculated based on the Response Evaluation Criteria in Solid Tumors (RECIST)/RECIST Immunotherapy and Cheson criteria (Phase 2 only). Response rate data will be summarized using proportions with exact 95% confidence intervals, means, standard deviations, and ranges.

    Time frame: 8 weeks

  4. Overall Survival (Phase 2 Only)

    Data will be summarized using Kaplan-Meier estimates for time to event data.

    Time frame: Up to 5 years

  5. Duration of Response (Phase 2 Only)

    Data will be summarized using Kaplan-Meier estimates for time to event data.

    Time frame: Up to 5 years

07

Results

Posted Mar 3, 2017

Participant flow

Study Phase 1
Participant flow — Study Phase 1
MilestoneIpilimumab 25 mgIpilimumab 25 mg and Radiation Therapy
Started30
Completed30
Not completed00
Study Phase 2
Participant flow — Study Phase 2
MilestoneIpilimumab 25 mgIpilimumab 25 mg and Radiation Therapy
Started00
Completed00
Not completed00

Outcome measures

PrimaryDose-limiting Toxicity

Safety as the percentage of patients in Phase 1 (ipilimumab monotherapy) of the study, who experienced dose-limiting toxicities (DLTs) or serious adverse events (SAEs), using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

Time frame:
4 weeks
Reported as:
Number · percentage of participants
Dose-limiting Toxicity
percentage of participantsIpilimumab 25 mgIpilimumab 25 mg and Radiation Therapy
Dose-limiting Toxicity0—
SecondaryImmune Response (Phase 2 Only)

Data will be summarized using proportions with exact 95% confidence intervals, means, standard deviations, and ranges.

Time frame:
4 weeks

No measurements were reported for this outcome.

SecondaryImmune Response (Phase 2 Only)

Data will be summarized using proportions with exact 95% confidence intervals, means, standard deviations, and ranges.

Time frame:
8 weeks

No measurements were reported for this outcome.

SecondaryResponse Rate (Phase 2 Only)

Response rates calculated based on the Response Evaluation Criteria in Solid Tumors (RECIST)/RECIST Immunotherapy and Cheson criteria (Phase 2 only). Response rate data will be summarized using proportions with exact 95% confidence intervals, means, standard deviations, and ranges.

Time frame:
8 weeks

No measurements were reported for this outcome.

SecondaryOverall Survival (Phase 2 Only)

Data will be summarized using Kaplan-Meier estimates for time to event data.

Time frame:
Up to 5 years

No measurements were reported for this outcome.

SecondaryDuration of Response (Phase 2 Only)

Data will be summarized using Kaplan-Meier estimates for time to event data.

Time frame:
Up to 5 years

No measurements were reported for this outcome.

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Ipilimumab 25 mg—0/3 (0%)1/3 (33.3%)
Ipilimumab 25 mg and Radiation Therapy———
Most frequent other events
Most frequent other events
EventIpilimumab 25 mgIpilimumab 25 mg and Radiation Therapy
Pain, injection siteSkin and subcutaneous tissue disorders1/3—

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Ipilimumab 25 mgIpilimumab 25 mg and Radiation TherapyTotal
<=18 years000
Between 18 and 65 years202
>=65 years101
Age, Continuous
Age, Continuous(years)Ipilimumab 25 mgIpilimumab 25 mg and Radiation TherapyTotal
Median61 (58 to 78)—61 (58 to 78)
Sex: Female, Male
Sex: Female, Male(Participants)Ipilimumab 25 mgIpilimumab 25 mg and Radiation TherapyTotal
Female2—2
Male1—1
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Ipilimumab 25 mgIpilimumab 25 mg and Radiation TherapyTotal
Hispanic or Latino0—0
Not Hispanic or Latino3—3
Unknown or Not Reported0—0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Ipilimumab 25 mgIpilimumab 25 mg and Radiation TherapyTotal
American Indian or Alaska Native0—0
Asian0—0
Native Hawaiian or Other Pacific Islander0—0
Black or African American0—0
White3—3
More than one race0—0
Unknown or Not Reported0—0
Region of Enrollment
Region of Enrollment(Participants)Ipilimumab 25 mgIpilimumab 25 mg and Radiation TherapyTotal
United States3—3
08

Study locations

1 site
  • Stanford University
    Stanford, California 94305, United States
09

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

10

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Feb 2013, a primary completion of Nov 2014 and a completion of Jun 2015. It does not say whether these dates are actual or estimated.

Results were first posted in Mar 2017, 2 years 4 months after primary completion.

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

Registered
Jan 14, 2013
First posted
Jan 16, 2013
Start
Feb 2013
Primary completionActual
Nov 2014
CompletionActual
Jun 2015
Results first posted
Mar 3, 2017
Last update
Jan 24, 2024
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 Jan 24, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01769222
Responsible party
George Albert Fisher (Professor of Medicine, Stanford University) — Principal investigator
First posted
Jan 16, 2013
Start date
Feb 2013
Primary completion
Nov 2014
Completion
Jun 2015
Results posted
Mar 3, 2017
Last update
Jan 24, 2024

Study contacts

George A. Fisher, MD, PhD
principal investigator · Stanford University

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 terminated, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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

Studies of the drug tested here: Ipilimumab

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