Ipilimumab With Carboplatin and Paclitaxel in Patients With Unresectable Stage III and Stage IV Melanoma

NCT ID: NCT01676649

Last Updated: 2021-02-18

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2026-05-31

Brief 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 response to ipilimumab with chemotherapy in patients with unresectable Stage III and Stage IV melanoma.

Conditions

Untreated Stage III Melanoma or Stage IV Melanoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

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)

Group Type: EXPERIMENTAL

Ipilimumab

Intervention Type: BIOLOGICAL

3 mg/kg

Carboplatin

Intervention Type: DRUG

AUC = 6

Paclitaxel

Intervention Type: DRUG

175 mg/m2

B

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)

Group Type: EXPERIMENTAL

Ipilimumab

Intervention Type: BIOLOGICAL

3 mg/kg

Carboplatin

Intervention Type: DRUG

AUC = 6

Paclitaxel

Intervention Type: DRUG

175 mg/m2

Interventions

Ipilimumab

3 mg/kg

Intervention Type: BIOLOGICAL

Carboplatin

AUC = 6

Intervention Type: DRUG

Paclitaxel

175 mg/m2

Intervention Type: DRUG

Other Intervention Names

YERVOY

Eligibility Criteria

Inclusion Criteria

• 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
• 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.

Exclusion Criteria

• 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).
• 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:

1. 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

2. have a positive pregnancy test at baseline, or

3. are pregnant or breastfeeding.

• Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (eg, infectious) illness.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jewish General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Wilson Miller

Medical Oncologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wilson Miller, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Jewish General Hospital

Rahima Jamal, MD

Role: PRINCIPAL_INVESTIGATOR

Notre-Dame Hospital (CHUM)

Locations

Jewish General Hospital

Montreal, Quebec, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 29157311 (View on PubMed)

Other Identifiers

CA184-195

Identifier Type: -

Identifier Source: org_study_id