Untreated Stage III Melanoma or Stage IV MelanomaPhase 2NCT01676649
Ipilimumab With Carboplatin and Paclitaxel in Patients With Unresectable Stage III and Stage IV Melanoma
A Phase 2 study testing Ipilimumab, Carboplatin and Paclitaxel in people with Untreated Stage III Melanoma or Stage IV Melanoma, run by Jewish General Hospital at 1 site in Canada.
Trial summary
The safety of the combination of ipilimumab with carboplatin/paclitaxel treatment with two different dosing schedules will be investigated in patients with metastatic melanoma. This protocol will also investigate both the clinical benefit of this combination and the features of the host immune system that may predict… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Untreated Stage III Melanoma or Stage IV Melanoma
- What is being tested?
- Ipilimumab, Carboplatin and Paclitaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2012to May 2026
- Phase
- Phase 2
- 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 to give written informed consent.
- Histologic diagnosis of malignant melanoma
- Untreated unresectable Stage III melanoma with N3 macroscopic lymph nodes or in-transit/satellite metastases or Stage IV melanoma (note that prior adjuvant melanoma therapy is permitted). Prior treatment with BRAF inhibitors in the metastatic setting is also permitted.
- Measurable/evaluable disease
- Required values for initial laboratory tests:
- WBC ≥ 2000/uL
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- ANC ≥ 1.5 x 10E9/L
- Platelets ≥ 100 x 10E9/L
- Hemoglobin ≥ 90 g/L (may be transfused)
- Creatinine Clearance ≥ 50 ml/min (calculated -Cockcroft-Gault)
- AST/ALT ≤ 2.5 x ULN for patients without liver metastasis,
- ≤ 5 times for liver metastases
- Bilirubin ≤ 2.5 x ULN
- No active or chronic infection with HIV, Hepatitis B, or Hepatitis C.
- ECOG Performance status of 0 or 1.
- Men and women, ≥ 18 years of age. 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 U/L. 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.
- 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 doseof investigational product] in such a manner that the risk of pregnancy is minimized.
Who cannot join
- Evidence of symptomatic CNS lesions as determined by the investigator (patients with asymptomatic lesions or previously irradiated or surgically resected are eligible).
- Any other malignancy from which the patient has been disease-free for less than one year, with the exception of adequately treated 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 AEs, such as a condition associated with frequent diarrhea.
- Patients with ≥ Grade 2 peripheral neuropathy.
- Any non-oncology vaccine therapy used for prevention of infectious diseases (for up to 1 month before or after any dose of ipilimumab).
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- A history of prior treatment with ipilimumab or prior CD137 agonist or CTLA 4 inhibitor or agonist.
- Concomitant therapy with any of the following: IL 2, interferon, or other non-study immunotherapy regimens; immunosuppressive agents; other investigation therapies; or chronic use of systemic corticosteroids.
- Women of childbearing potential (WOCBP), defined above, who:
- are unwilling or unable to use an acceptable method of contraception to avoid pregnancy for their entire study period and for at least 26 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Study of Ipilimumab in Combination With Carboplatin and Paclitaxel in Patients With Unresectable Stage III or Stage IV Melanoma
The safety of the combination of ipilimumab with carboplatin/paclitaxel treatment with two different dosing schedules will be investigated in patients with metastatic melanoma. This protocol will also investigate both the clinical benefit of this combination and the features of the host immune system that may predict response to ipilimumab with chemotherapy in patients with unresectable Stage III and Stage IV melanoma.
- Being tested
- Ipilimumab, Carboplatin, Paclitaxel
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IpilimumabBiological
Also called YERVOY
3 mg/kg
CarboplatinDrug
AUC = 6
PaclitaxelDrug
175 mg/m2
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Arm A: Carboplatin (week 1, week 4, week 7, week 10, and week 13) Paclitaxel (week 1, week 4, week 7, week 10, and week 13) Ipilimumab (week 4, week 7, week 10, and week 13) Receives: Biological: Ipilimumab; Drug: Carboplatin; Drug: Paclitaxel |
| B | Experimental | Carboplatin (week 1, week 4, week 7, week 10, and week 13) Paclitaxel (week 1, week 4, week 7, week 10, and week 13) Ipilimumab (week 5, week 8, week 11, and week 14) Receives: Biological: Ipilimumab; Drug: Carboplatin; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Incidence of adverse events
Measured: 24 months
Secondary outcomes (4)
Putative Early Cellular and/or Molecular Biomarker levels
Measured: 27 months
To determine ORR and clinical benefit rate (ORR + SD ≥ 24 weeks), by immune related response criteria (irRC) and modified WHO criteria (mWHO) of ipilimumab when given with carboplatin and paclitaxel at two different dosing regimens.
Measured: 48 months
To determine the overall survival (OS) of patients receiving ipilimumab with carboplatin and paclitaxel.
Measured: 48 months
To determine progression free survival (PFS) per irRC and mWHO of patients receiving ipilimumab with carboplatin and paclitaxel.
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2012 (estimated)
- Study startNov 2012
- Primary completionFeb 2017
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Untreated Stage III Melanoma or Stage IV MelanomaStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jewish General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wilson Miller, Jewish General Hospital
- Investigators
- Wilson Miller, MD, PhD, Principal investigator, Jewish General HospitalRahima Jamal, MD, Principal investigator, Notre-Dame Hospital (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01676649
- Sponsor's protocol ID
- CA184-195
- Status last verified
- Feb 2021
- First submitted
- 29 Aug 2012
- Last updated
- 18 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Jamal R, Lapointe R, Cocolakis E, Thebault P, Kazemi S, Friedmann JE, Dionne J, Cailhier JF, Belanger K, Ayoub JP, Le H, Lambert C, El-Hajjar J, van Kempen LC, Spatz A, Miller WH Jr. Peripheral and local predictive immune signatures identified in a phase II trial of ipilimumab with carboplatin/paclitaxel in unresectable stage III or stage IV melanoma. J Immunother Cancer. 2017 Nov 21;5(1):83. doi: 10.1186/s40425-017-0290-x.
PubMed 29157311
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Ipilimumab in Combination With Carboplatin and Paclitaxel in Patients With Unresectable Stage III or Stage IV Melanoma
- ClinicalTrials.gov ID
- NCT01676649
- Acronym / sponsor ID
- CA184-195
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Jewish General HospitalUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Feb 2017 (actual)
- Study completion
- May 2026 (estimated)
- First posted
- 31 Aug 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.
The safety of the combination of ipilimumab with carboplatin/paclitaxel treatment with two different dosing schedules will be investigated in patients with metastatic melanoma. This protocol will also investigate both the clinical benefit of this combination and the features of the host immune system that may predict response to ipilimumab with chemotherapy in patients with unresectable Stage III and Stage IV melanoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Biological: Ipilimumab, Drug: Carboplatin, Drug: PaclitaxelArm A: Carboplatin (week 1, week 4, week 7, week 10, and week 13) Paclitaxel (week 1, week 4, week 7, week 10, and week 13) Ipilimumab (week 4, week 7, week 10, and week 13) |
| B | Experimental | Biological: Ipilimumab, Drug: Carboplatin, Drug: PaclitaxelCarboplatin (week 1, week 4, week 7, week 10, and week 13) Paclitaxel (week 1, week 4, week 7, week 10, and week 13) Ipilimumab (week 5, week 8, week 11, and week 14) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Willing and able to give written informed consent.
- Histologic diagnosis of malignant melanoma
- Untreated unresectable Stage III melanoma with N3 macroscopic lymph nodes or in-transit/satellite metastases or Stage IV melanoma (note that prior adjuvant melanoma therapy is permitted). Prior treatment with BRAF inhibitors in the metastatic setting is also permitted.
- Measurable/evaluable disease
- Required values for initial laboratory tests:
Key exclusion criteria (13 listed)
- Evidence of symptomatic CNS lesions as determined by the investigator (patients with asymptomatic lesions or previously irradiated or surgically resected are eligible).
- Any other malignancy from which the patient has been disease-free for less than one year, with the exception of adequately treated 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 AEs, such as a condition associated with frequent diarrhea.
- Patients with ≥ Grade 2 peripheral neuropathy.
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 |
|---|---|---|
| IpilimumabAlso: YERVOY3 mg/kg | Biological | A, B |
| CarboplatinAUC = 6 | Drug | A, B |
| Paclitaxel175 mg/m2 | Drug | A, B |
Primary outcome
Safety: Incidence of adverse events
Time frame: 24 months
4 secondary outcomes
Putative Early Cellular and/or Molecular Biomarker levels
Time frame: 27 months
To determine ORR and clinical benefit rate (ORR + SD ≥ 24 weeks), by immune related response criteria (irRC) and modified WHO criteria (mWHO) of ipilimumab when given with carboplatin and paclitaxel at two different dosing regimens.
Time frame: 48 months
To determine the overall survival (OS) of patients receiving ipilimumab with carboplatin and paclitaxel.
Time frame: 48 months
To determine progression free survival (PFS) per irRC and mWHO of patients receiving ipilimumab with carboplatin and paclitaxel.
Time frame: 48 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
- Derived from this study: PubMed 29157311Jamal R, Lapointe R, Cocolakis E, Thebault P, Kazemi S, Friedmann JE, Dionne J, Cailhier JF, Belanger K, Ayoub JP, Le H, Lambert C, El-Hajjar J, van Kempen LC, Spatz A, Miller WH Jr. Peripheral and local predictive immune signatures identified in a phase II trial of ipilimumab with carboplatin/paclitaxel in unresectable stage III or stage IV melanoma. J Immunother Cancer. 2017 Nov 21;5(1):83. doi: 10.1186/s40425-017-0290-x.
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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.
Wilson Miller, MD, PhD principal investigator
Jewish General Hospital
Rahima Jamal, MD principal investigator
Notre-Dame Hospital (CHUM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ipilimumab, Carboplatin and Paclitaxel in people with Untreated Stage III Melanoma or Stage IV Melanoma, run by Jewish General Hospital 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 20 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 18 Feb 2021. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Safety: Incidence of adverse events (time frame: 24 months). 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 NCT01676649, which also lists 1 linked publication.
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 18 Feb 2021.