Previously Untreated and Histologically Confirmed Stage III (Unresectable) or Stage IV MelanomaNCT01715077
Study of Ipilimumab in the Immune System
A study testing Ipilimumab at 3 mg/kg dose in people with Previously Untreated and Histologically Confirmed Stage III (Unresectable) or Stage IV Melanoma, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Participants will be taking 3 mg/kg ipilimumab intravenously over a 90-minute period every 3 weeks for a total of four doses. Tumor-infiltrating lymphocytes (TILs)will be analyzed for functional characteristics. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Previously Untreated and Histologically Confirmed Stage III (Unresectable) or Stage IV Melanoma
- What is being tested?
- Ipilimumab at 3 mg/kg dose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2012to Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able give written informed consent.
- Previously untreated (adjuvant interferon is acceptable), and histologically confirmed Stage III (unresectable) or Stage IV melanoma with at least 2 metastatic lesions, (one amenable to resection that measures over 0.75 cm3 by volume AND another amenable to 3 X core biopsy OR resection that measures over 0.5 cm3) at study entry AND at least 1 additional RECIST measurable lesion must be present for study entry, other than the 2 identified for resection/biopsy, defined as a lesion that can be accurately measured in two perpendicular diameters, as per RECIST by CT scan, MRI, or calipers by clinical exam.
- Subjects with asymptomatic or previously treated brain metastases are only eligible for enrollment provided they have evidence of 30 day stability of the brain metastasis prior to the date of registration. "Stability" being no change in the imaging modality used (CT or MRI) at the baseline and 30 day time point. (Systemic steroids should be avoided if possible, or the subject should be stable on the lowest clinically effective dose of 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 surgery or radiation, or immunotherapy (IFN-alpha), and recovered from any clinically significant toxicity experienced during treatment.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy of ≥ 16 weeks.
Show all 11Show fewer
- Subjects must have the complete set of baseline (screening/baseline) radiographic images, including but not limited to brain, chest, abdomen, pelvis, and bone scans (if applicable). The images can be accepted if obtained 6 weeks before initiation of ipilimumab.
- Required values for initial laboratory tests: WBC > 2.0 x 109/L; ANC > 1.0 x 109/L; Platelets > 100 x 109/L; Hemoglobin > 90 g/L (> 80 g/L; may be transfused); Creatinine < 2.0 x ULN; AST/ALT < 2.5 x ULN for patients without liver metastasis, < 5 times for liver metastases; Bilirubin < 2.0 x ULN, (except patients with Gilbert's Syndrome, who must have a total bilirubin less than 51.3 µmol/L); INR < 1.3
- No active or chronic infection HIV, Hepatitis B, or Hepatitis C.
- Men and women, ≥ 18 years of age.
- WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours before the start of ipilimumab.
Who cannot join
- Sex and Reproductive Status: a) WOCBP and men of fathering potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study and for up to 26 weeks after the last dose of investigational product. Adequate contraception for women is defined as oral contraceptives, other hormonal contraceptives or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides), abstinence or sterile partner (eg, vasectomy). Adequate contraception for men is defined as abstinence, sterile partner, condoms, or vasectomy. b) Women who are pregnant or breastfeeding.
- Target Disease Exceptions: a) Subjects on any other systemic therapy for cancer, including any other experimental treatment. b) Prior treatment with an anti-CTLA-4 antibody if treatment failure was due to irAEs. If a subject was discontinued from the prior anti-CTLA-4 treatment due to an AE or SAE, regardless of the type of event, that discontinuation constitutes an exclusion criterion. If irAEs were serious enough to require a subject's withdrawal from prior treatment, the subject should be excluded from this study. c) Prior treatment with chemotherapy/biochemotherapy/immunotherapy for systemic disease for melanoma (prior treatment with IFN-alpha immunotherapy is allowed)..
- Primary ocular and mucosal melanomas are not allowed.
- Medical History and Concurrent Diseases: a) Autoimmune disease: subjects with a documented history of inflammatory bowel disease, including ulcerative colitis and Crohn's disease are excluded from this study as are subjects with a history of symptomatic disease (eg, rheumatoid arthritis, systemic progressive sclerosis [scleroderma], Systemic Lupus Erythematosus, autoimmune vasculitis [eg, Wegener's Granulomatosis]). Subjects with motor neuropathy considered of autoimmune origin (eg, Guillain-Barre Syndrome and Myasthenia Gravis) are excluded from this study. b) Any subject who has a life-threatening condition that requires high-dose immunosuppressant(s). c) Presence of known HIV, hepatitis B or hepatitis C infection, regardless of control on antiviral therapy. d) Subjects with melanoma who have another active, concurrent, malignant disease with the exception of subjects with adequately treated basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix.
- Other Exclusion Criteria: a) Prisoners or subjects who are involuntarily incarcerated. b) Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness. c) Any underlying medical or psychiatric condition that, in the opinion of the investigator, could make the administration of ipilimumab hazardous or could obscure the interpretation of adverse events. d) Any non-oncology vaccine therapy used for prevention of infectious diseases for up to 4 weeks before or after any dose of ipilimumab, with the exceptions of amantadine and flumadine.
- Any acute or chronic treatment with warfarin or anti-platelet agent (aspirin is allowed up to a dose of 300 mg daily) including clopidogrel. Heparin, low molecular weight heparin, any heparinoid are allowed after appropriate cessation (usually 24 hours prior to induction).
- Any known or suspected bleeding diathesis on the basis or personal or family history (including diagnoses of von Willebrands disease or other familial factor deficiency).
- The risk of the excision involves a significant risk of morbidity or mortality due to its size, location or vascularity (at the discretion of the principal investigators).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Correlative Study of Melanoma Tumor-Infiltrating Lymphocytes (TILs) and Response to Ipilimumab
Participants will be taking 3 mg/kg ipilimumab intravenously over a 90-minute period every 3 weeks for a total of four doses. Tumor-infiltrating lymphocytes (TILs)will be analyzed for functional characteristics.
Read the detailed description
STUDY DESIGN
- Screening
- Assessment of the subject's eligibility to participate as determined by the inclusion/exclusion criteria.
- Biopsy schedule
- Subjects will be biopsied according to the schedule in Section 7.
- Induction
- The recommended induction dose of ipilimumab is 3 mg/kg administered intravenously over a 90-minute period every 3 weeks for a total of four doses, as tolerated.
- Laboratory evaluations should be performed and the results examined before administration of each ipilimumab dose.
- As durable disease stabilization and/or objective tumor response can be seen after early progression before Week 12, it is recommended that, in the absence of dose-limiting toxicities (eg, serious immune-mediated adverse reactions), all four doses of ipilimumab be administered over the initial 12 weeks even in the setting of apparent clinical progression, providing the subject's performance status remains stable.
- All subjects who enter the induction period, including those who may have discontinued treatment for drug-related AEs and/or who have evidence of clinical progression during the induction period, should obtain a 12-week tumor assessment.
- Based on clinical experience in the ongoing and completed melanoma studies, the following recommendations apply for subject management in light of the Week 12 or later tumor assessments:
- The appearance of new lesions in subjects with other stable or shrinking baseline tumor burden may be experiencing clinical benefit and should continue in follow-up and/or maintenance therapy before alternative anti-cancer agents are considered. These subjects can be seen to have continued tumor shrinkage in follow-up scans.
- As long as overall tumor burden is stable or decreasing, subjects should remain in follow-up and/or maintenance (see below), even in the presence of new lesions.
- Clinical progression warranting alternative anti-cancer treatment should be considered only in subjects whose overall tumor burden appears to be substantially increased and/or in subjects whose performance status is decreased.
- Patients are eligible for retreatment treatments with ipilimumab on this protocol
- Follow-up
- Subjects will be required to attend a follow-up visit within 90 days of the last ipilimumab treatment.
- Re-treatment
Patients who received ipilimumab at any dose in a prior/parent study and have met each of the following criteria:
- Had no unacceptable toxicity requiring ipilimumab discontinuation; OR
- Patients who permanently discontinued treatment due to select irAEs as follows:
- Reversible autoimmune hepatitis
- Medically manageable endocrinopathy
- Reversible dermatological toxicity AND
- Have experienced documented disease progression after demonstrating expanded clinical benefit.
Expanded clinical benefit is defined as:
- Patients whose disease is responding (partial response, complete response); or
- Patients whose disease was stable more than or equal to 3 months.
- Patients who demonstrated mixed or delayed response.
The mixed or delayed response is defined as follows:
Patients with Mixed Response: defined as at least 50% reduction in the bidimensional size of one or more non-cystic lesions, even in the presence of any new lesions.
Patients with Delayed Response: defined as objective response (PR or CR) following progressive disease, occurring any time after Week 12 in the prior/parent protocol, in patients who have not received therapy with a non ipilimumab anti-cancer agent (approved or experimental) between the PD and objective response.
Patients with select irAEs related to ipilimumab that have completely resolved with immunosuppressive therapy or are adequately controlled with hormone therapy, may be considered for further re-treatment with ipilimumab under this study, at the time of disease progression. The list of completely reversible or medically managed immune-related adverse events (irAEs) eligible for consideration are:
- Reversible autoimmune hepatitis
- Medically managed endocrinopathy
- Reversible dermatological toxicity All other irAEs are not considered eligible for re-treatment, including, but not limited to, greater or equal Grade 3 colitis or diarrhea, or uveitis of any grade.
- Conditions
- Previously Untreated and Histologically Confirmed Stage III (Unresectable) or Stage IV Melanoma
- Being tested
- Ipilimumab at 3 mg/kg dose
- Keywords
- melanoma, stage IV, stage III, unresectable
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ipilimumab at 3 mg/kg doseDrug
| Study group | Role | What they receive |
|---|---|---|
| Ipilimumab | Experimental | The recommended induction dose of ipilimumab is 3 mg/kg administered intravenously over a 90-minute period every 3 weeks for a total of four doses, as guided by laboratory tests and patient assessment. Receives: Drug: Ipilimumab at 3 mg/kg dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
TILs characteristics
Tumor-infiltrating lymphocytes (TILs)will be observed before and after 3 mg/kg Ipilimumab is administered on patients with Stage III (unresectable) or Stage IV melanoma.
Measured: 2 years
Secondary outcomes (1)
Progression Free Survival (PFS) and Overall Survival (OS)
To evaluate the Progression Free Survival (PFS) and Overall Survival (OS) in patients with previously untreated, metastatic melanoma.
Measured: 2 years on average
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Previously Untreated and Histologically Confirmed Stage III (Unresectable) or Stage IV MelanomaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anthony Joshua, M.D, Principal investigator, UHN-Princess Margaet Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01715077
- Sponsor's protocol ID
- CA184-181
- Status last verified
- Aug 2018
- First submitted
- 12 Oct 2012
- Last updated
- 13 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lenschow DJ, Walunas TL, Bluestone JA. CD28/B7 system of T cell costimulation. Annu Rev Immunol. 1996;14:233-58. doi: 10.1146/annurev.immunol.14.1.233.
PubMed 8717514Schwartz RH. Costimulation of T lymphocytes: the role of CD28, CTLA-4, and B7/BB1 in interleukin-2 production and immunotherapy. Cell. 1992 Dec 24;71(7):1065-8. doi: 10.1016/s0092-8674(05)80055-8. No abstract available.
PubMed 1335362Chen L, Ashe S, Brady WA, Hellstrom I, Hellstrom KE, Ledbetter JA, McGowan P, Linsley PS. Costimulation of antitumor immunity by the B7 counterreceptor for the T lymphocyte molecules CD28 and CTLA-4. Cell. 1992 Dec 24;71(7):1093-102. doi: 10.1016/s0092-8674(05)80059-5.
PubMed 1335364Clemente CG, Mihm MC Jr, Bufalino R, Zurrida S, Collini P, Cascinelli N. Prognostic value of tumor infiltrating lymphocytes in the vertical growth phase of primary cutaneous melanoma. Cancer. 1996 Apr 1;77(7):1303-10. doi: 10.1002/(SICI)1097-0142(19960401)77:73.0.CO;2-5.
PubMed 8608507Hamid, O., Chasalow, S. D., Tsuchihashi, Z., Alaparthy, S., Galbraith, S., and Berman, D. Association of baseline and on-study tumor biopsy markers with clinical activity in patients (pts) with advanced melanoma treated with ipilimumab. J Clin Oncol 27, 15s. 2009.
Hodi FS, Butler M, Oble DA, Seiden MV, Haluska FG, Kruse A, Macrae S, Nelson M, Canning C, Lowy I, Korman A, Lautz D, Russell S, Jaklitsch MT, Ramaiya N, Chen TC, Neuberg D, Allison JP, Mihm MC, Dranoff G. Immunologic and clinical effects of antibody blockade of cytotoxic T lymphocyte-associated antigen 4 in previously vaccinated cancer patients. Proc Natl Acad Sci U S A. 2008 Feb 26;105(8):3005-10. doi: 10.1073/pnas.0712237105. Epub 2008 Feb 19.
PubMed 18287062Hodi FS, Mihm MC, Soiffer RJ, Haluska FG, Butler M, Seiden MV, Davis T, Henry-Spires R, MacRae S, Willman A, Padera R, Jaklitsch MT, Shankar S, Chen TC, Korman A, Allison JP, Dranoff G. Biologic activity of cytotoxic T lymphocyte-associated antigen 4 antibody blockade in previously vaccinated metastatic melanoma and ovarian carcinoma patients. Proc Natl Acad Sci U S A. 2003 Apr 15;100(8):4712-7. doi: 10.1073/pnas.0830997100. Epub 2003 Apr 7.
PubMed 12682289
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Correlative Study of Melanoma Tumor-Infiltrating Lymphocytes (TILs) and Response to Ipilimumab
- ClinicalTrials.gov ID
- NCT01715077
- Acronym / sponsor ID
- CA184-181
- Conditions
- Previously Untreated and Histologically Confirmed Stage III (Unresectable) or Stage IV Melanoma
- Keywords
- melanoma, stage IV, stage III, unresectable
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 26 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Participants will be taking 3 mg/kg ipilimumab intravenously over a 90-minute period every 3 weeks for a total of four doses. Tumor-infiltrating lymphocytes (TILs)will be analyzed for functional characteristics.
Detailed description
STUDY DESIGN
- Screening
- Assessment of the subject's eligibility to participate as determined by the inclusion/exclusion criteria.
- Biopsy schedule
- Subjects will be biopsied according to the schedule in Section 7.
- Induction
- The recommended induction dose of ipilimumab is 3 mg/kg administered intravenously over a 90-minute period every 3 weeks for a total of four doses, as tolerated.
- Laboratory evaluations should be performed and the results examined before administration of each ipilimumab dose.
- As durable disease stabilization and/or objective tumor response can be seen after early progression before Week 12, it is recommended that, in the absence of dose-limiting toxicities (eg, serious immune-mediated adverse reactions), all four doses of ipilimumab be administered over the initial 12 weeks even in the setting of apparent clinical progression, providing the subject's performance status remains stable.
- All subjects who enter the induction period, including those who may have discontinued treatment for drug-related AEs and/or who have evidence of clinical progression during the induction period, should obtain a 12-week tumor assessment.
- Based on clinical experience in the ongoing and completed melanoma studies, the following recommendations apply for subject management in light of the Week 12 or later tumor assessments:
- The appearance of new lesions in subjects with other stable or shrinking baseline tumor burden may be experiencing clinical benefit and should continue in follow-up and/or maintenance therapy before alternative anti-cancer agents are considered. These subjects can be seen to have continued tumor shrinkage in follow-up scans.
- As long as overall tumor burden is stable or decreasing, subjects should remain in follow-up and/or maintenance (see below), even in the presence of new lesions.
- Clinical progression warranting alternative anti-cancer treatment should be considered only in subjects whose overall tumor burden appears to be substantially increased and/or in subjects whose performance status is decreased.
- Patients are eligible for retreatment treatments with ipilimumab on this protocol
- Follow-up
- Subjects will be required to attend a follow-up visit within 90 days of the last ipilimumab treatment.
- Re-treatment
Patients who received ipilimumab at any dose in a prior/parent study and have met each of the following criteria:
- Had no unacceptable toxicity requiring ipilimumab discontinuation; OR
- Patients who permanently discontinued treatment due to select irAEs as follows:
- Reversible autoimmune hepatitis
- Medically manageable endocrinopathy
- Reversible dermatological toxicity AND
- Have experienced documented disease progression after demonstrating expanded clinical benefit.
Expanded clinical benefit is defined as:
- Patients whose disease is responding (partial response, complete response); or
- Patients whose disease was stable more than or equal to 3 months.
- Patients who demonstrated mixed or delayed response.
The mixed or delayed response is defined as follows:
Patients with Mixed Response: defined as at least 50% reduction in the bidimensional size of one or more non-cystic lesions, even in the presence of any new lesions.
Patients with Delayed Response: defined as objective response (PR or CR) following progressive disease, occurring any time after Week 12 in the prior/parent protocol, in patients who have not received therapy with a non ipilimumab anti-cancer agent (approved or experimental) between the PD and objective response.
Patients with select irAEs related to ipilimumab that have completely resolved with immunosuppressive therapy or are adequately controlled with hormone therapy, may be considered for further re-treatment with ipilimumab under this study, at the time of disease progression. The list of completely reversible or medically managed immune-related adverse events (irAEs) eligible for consideration are:
- Reversible autoimmune hepatitis
- Medically managed endocrinopathy
- Reversible dermatological toxicity All other irAEs are not considered eligible for re-treatment, including, but not limited to, greater or equal Grade 3 colitis or diarrhea, or uveitis of any grade.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ipilimumab | Experimental | Drug: Ipilimumab at 3 mg/kg doseThe recommended induction dose of ipilimumab is 3 mg/kg administered intravenously over a 90-minute period every 3 weeks for a total of four doses, as guided by laboratory tests and patient assessment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Willing and able give written informed consent.
- Previously untreated (adjuvant interferon is acceptable), and histologically confirmed Stage III (unresectable) or Stage IV melanoma with at least 2 metastatic lesions, (one amenable to resection that measures over 0.75 cm3 by volume AND another amenable to 3 X core biopsy OR resection that measures over 0.5 cm3) at study entry AND at least 1 additional RECIST measurable lesion must be present for study entry, other than the 2 identified for resection/biopsy, defined as a lesion that can be accurately measured in two perpendicular diameters, as per RECIST by CT scan, MRI, or calipers by clinical exam.
- Subjects with asymptomatic or previously treated brain metastases are only eligible for enrollment provided they have evidence of 30 day stability of the brain metastasis prior to the date of registration. "Stability" being no change in the imaging modality used (CT or MRI) at the baseline and 30 day time point. (Systemic steroids should be avoided if possible, or the subject should be stable on the lowest clinically effective dose of 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 surgery or radiation, or immunotherapy (IFN-alpha), and recovered from any clinically significant toxicity experienced during treatment.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Key exclusion criteria (8 listed)
- Sex and Reproductive Status: a) WOCBP and men of fathering potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study and for up to 26 weeks after the last dose of investigational product. Adequate contraception for women is defined as oral contraceptives, other hormonal contraceptives or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides), abstinence or sterile partner (eg, vasectomy). Adequate contraception for men is defined as abstinence, sterile partner, condoms, or vasectomy. b) Women who are pregnant or breastfeeding.
- Target Disease Exceptions: a) Subjects on any other systemic therapy for cancer, including any other experimental treatment. b) Prior treatment with an anti-CTLA-4 antibody if treatment failure was due to irAEs. If a subject was discontinued from the prior anti-CTLA-4 treatment due to an AE or SAE, regardless of the type of event, that discontinuation constitutes an exclusion criterion. If irAEs were serious enough to require a subject's withdrawal from prior treatment, the subject should be excluded from this study. c) Prior treatment with chemotherapy/biochemotherapy/immunotherapy for systemic disease for melanoma (prior treatment with IFN-alpha immunotherapy is allowed)..
- Primary ocular and mucosal melanomas are not allowed.
- Medical History and Concurrent Diseases: a) Autoimmune disease: subjects with a documented history of inflammatory bowel disease, including ulcerative colitis and Crohn's disease are excluded from this study as are subjects with a history of symptomatic disease (eg, rheumatoid arthritis, systemic progressive sclerosis [scleroderma], Systemic Lupus Erythematosus, autoimmune vasculitis [eg, Wegener's Granulomatosis]). Subjects with motor neuropathy considered of autoimmune origin (eg, Guillain-Barre Syndrome and Myasthenia Gravis) are excluded from this study. b) Any subject who has a life-threatening condition that requires high-dose immunosuppressant(s). c) Presence of known HIV, hepatitis B or hepatitis C infection, regardless of control on antiviral therapy. d) Subjects with melanoma who have another active, concurrent, malignant disease with the exception of subjects with adequately treated basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix.
- Other Exclusion Criteria: a) Prisoners or subjects who are involuntarily incarcerated. b) Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness. c) Any underlying medical or psychiatric condition that, in the opinion of the investigator, could make the administration of ipilimumab hazardous or could obscure the interpretation of adverse events. d) Any non-oncology vaccine therapy used for prevention of infectious diseases for up to 4 weeks before or after any dose of ipilimumab, with the exceptions of amantadine and flumadine.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ipilimumab at 3 mg/kg dose | Drug | Ipilimumab |
Primary outcome
TILs characteristics
Time frame: 2 years
Tumor-infiltrating lymphocytes (TILs)will be observed before and after 3 mg/kg Ipilimumab is administered on patients with Stage III (unresectable) or Stage IV melanoma.
1 secondary outcome
Progression Free Survival (PFS) and Overall Survival (OS)
Time frame: 2 years on average
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2018.
- Background: PubMed 8717514Lenschow DJ, Walunas TL, Bluestone JA. CD28/B7 system of T cell costimulation. Annu Rev Immunol. 1996;14:233-58. doi: 10.1146/annurev.immunol.14.1.233.
- Background: PubMed 1335362Schwartz RH. Costimulation of T lymphocytes: the role of CD28, CTLA-4, and B7/BB1 in interleukin-2 production and immunotherapy. Cell. 1992 Dec 24;71(7):1065-8. doi: 10.1016/s0092-8674(05)80055-8. No abstract available.
- Background: PubMed 1335364Chen L, Ashe S, Brady WA, Hellstrom I, Hellstrom KE, Ledbetter JA, McGowan P, Linsley PS. Costimulation of antitumor immunity by the B7 counterreceptor for the T lymphocyte molecules CD28 and CTLA-4. Cell. 1992 Dec 24;71(7):1093-102. doi: 10.1016/s0092-8674(05)80059-5.
- Background: PubMed 8608507Clemente CG, Mihm MC Jr, Bufalino R, Zurrida S, Collini P, Cascinelli N. Prognostic value of tumor infiltrating lymphocytes in the vertical growth phase of primary cutaneous melanoma. Cancer. 1996 Apr 1;77(7):1303-10. doi: 10.1002/(SICI)1097-0142(19960401)77:73.0.CO;2-5.
- BackgroundHamid, O., Chasalow, S. D., Tsuchihashi, Z., Alaparthy, S., Galbraith, S., and Berman, D. Association of baseline and on-study tumor biopsy markers with clinical activity in patients (pts) with advanced melanoma treated with ipilimumab. J Clin Oncol 27, 15s. 2009.
- Background: PubMed 18287062Hodi FS, Butler M, Oble DA, Seiden MV, Haluska FG, Kruse A, Macrae S, Nelson M, Canning C, Lowy I, Korman A, Lautz D, Russell S, Jaklitsch MT, Ramaiya N, Chen TC, Neuberg D, Allison JP, Mihm MC, Dranoff G. Immunologic and clinical effects of antibody blockade of cytotoxic T lymphocyte-associated antigen 4 in previously vaccinated cancer patients. Proc Natl Acad Sci U S A. 2008 Feb 26;105(8):3005-10. doi: 10.1073/pnas.0712237105. Epub 2008 Feb 19.
- Background: PubMed 12682289Hodi FS, Mihm MC, Soiffer RJ, Haluska FG, Butler M, Seiden MV, Davis T, Henry-Spires R, MacRae S, Willman A, Padera R, Jaklitsch MT, Shankar S, Chen TC, Korman A, Allison JP, Dranoff G. Biologic activity of cytotoxic T lymphocyte-associated antigen 4 antibody blockade in previously vaccinated metastatic melanoma and ovarian carcinoma patients. Proc Natl Acad Sci U S A. 2003 Apr 15;100(8):4712-7. doi: 10.1073/pnas.0830997100. Epub 2003 Apr 7.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony Joshua, M.D principal investigator
UHN-Princess Margaet Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ipilimumab at 3 mg/kg dose in people with Previously Untreated and Histologically Confirmed Stage III (Unresectable) or Stage IV Melanoma, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TILs characteristics (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01715077, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2018.