Phase II Study of Abraxane Plus Ipilimumab in Patients With Metastatic Melanoma

NCT01827111 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: 2011-1157NCI-2014-01238
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to learn if the combination of ipilimumab and ABI-007 (abraxane) can help to control metastatic melanoma. The safety of this drug combination will also be studied. Ipilimumab is designed to increase the immune system's ability to fight cancer. Abraxane is designed to stop cancer cells from making new DNA (the genetic material of cells). This may stop the cancer cells from dividing into new cells.

Conditions

Melanoma

Keywords

Melanoma; Metastatic Melanoma; Advanced stage IV melanoma; Unresectable stage III mucosal melanoma; Cutaneous melanoma; Progression-free survival; (PFS); ABI-007; Nab-paclitaxel; Paclitaxel; Abraxane; Ipilimumab; Yervoy; BMS-734016; MDX010

Outcome Measures

Primary Outcomes (2)

• Median Overall Survival Response to Abraxane Plus Ipilimumab Therapy

  Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v 1.1) was used. Complete Response (CR)= Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm, no new lesions; Partial Response (PR)= At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 50 months

• Median Progression Free Survival

  Progression-free survival (PFS) is the time from random assignment in a clinical trial to disease progression or death from any cause.

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 50 months

Study Arms (1)

ABI-007 + Ipilimumab

EXPERIMENTAL

Starting dose of ABI-007 is 150 mg/m2 administered by vein on days 1, 8, 15 every 28 days. Ipilimumab 3 mg/kg by vein over 90 minutes on day 1. Ipilimumab dose repeated every 21 days for a total of 4 doses. Every 2 months for 6 months, then every 3 months for up to 2 years, participant contacted by telephone. Each call should last about 5 minutes.

Drug: ABI-007; Drug: Ipilimumab; Behavioral: Phone Call

Interventions

ABI-007 DRUG

Starting dose of ABI-007 is 150 mg/m2 administered by vein on days 1, 8, 15 every 28 days. The cycle length for ABI-007 is 28 days.

Also known as: Nab-paclitaxel, Paclitaxel, Abraxane

ABI-007 + Ipilimumab

Ipilimumab DRUG

3 mg/kg by vein over 90 minutes on day 1. Ipilimumab dose repeated every 21 days for a total of 4 doses.

Also known as: Yervoy, BMS-734016, MDX010

ABI-007 + Ipilimumab

Phone Call BEHAVIORAL

Every 2 months for 6 months, then every 3 months for up to 2 years, participant contacted by telephone. Each call should last about 5 minutes.

ABI-007 + Ipilimumab

Eligibility Criteria

• Age: 12 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with histologically documented diagnosis of advanced stage IV or unresectable stage III mucosal or cutaneous melanoma are eligible.
• They must have recurrent melanoma with measurable or evaluable sites of disease, 1.0 cm or larger, in order to assess the response to treatment by the immune-related response criteria (irRC).
• Patients should not have been previously treated with cytotoxic drugs and immunotherapeutic agents for unresectable Stage III or Stage IV disease. Prior Ipilimumab in metastatic setting is not allowed. Prior therapy may include one line of targeted therapy for metastatic disease ie BRAF or MEK inhibitor. At least 3 weeks should have passed since the last dose of prior adjuvant interferon therapy and prior targeted therapies, and all previous therapy related toxicities should have resolved before starting study treatment. Prior adjuvant interferon is permitted. Prior cytotoxic therapy in adjuvant or metastatic setting is not allowed. Prior Ipilimumab in adjuvant setting is not allowed. Prior adjuvant therapy with targeted therapy including but not limited to B-RAF, MEK inhibitors etc. is allowed. Prior palliative radiation therapy for metastatic melanoma is permitted provided the patient has unirradiated metastatic sites for response evaluation and has fully recovered from its toxicity.
• Patients between 12 years of age and 70 years of age with an ECOG performance status of 0 or 1 will be eligible
• They should have normal blood counts with a white blood cell count of more than or equal to 3000/mm\^3 an absolute neutrophil count of more than or equal to 1500/mm\^3 and a platelet count of more than 100,000/mm\^3, Hemoglobin \> 9.0 g/dL and have no impairment of renal function (serum creatinine less than 1.1 mg/dl for females and less than 1.4 mg/dl for males), hepatic function (serum bilirubin level of less than 1.5 mg/dl, AST and ALT \</= 2.5X ULN unless presence of hepatic metastasis in which case AST and ALT \</= 5X ULN are acceptable. Alk Phos \</= 2.5X ULN ) and no evidence of significant cardiac or pulmonary dysfunction.
• They should have no significant intercurrent illness such as an active infection associated with fever lasting more than 24 hours requiring antibiotics, uncontrolled psychiatric illness, hypercalcemia (calcium greater than 11 mg), or active GI bleeding. Females of child-bearing potential (non-childbearing is defined as greater than one year post-menopausal or surgically sterilized) must use acceptable contraceptive methods( abstinence, intrauterine device, oral contraceptive or double barrier devices) and must have a negative serum or urine pregnancy test within 72 hours prior to beginning treatment on this trial. Sexually active men must also use acceptable contraceptive methods for the duration of time on study and signed informed consent .

You may not qualify if:

• Patients with metastatic uveal melanoma
• Patients with bone metastases only.
• Patients with symptomatic brain or spinal cord metastases or requiring steroid therapy and patients with leptomeningeal disease. Patients with treated and stable CNS metastasis for 3 months or more, off steroids are eligible for the study. No major surgery or radiation therapy within 21 days before starting treatment.
• Patients with significant cardiac illness such as symptomatic coronary artery disease or previous history of myocardial infarction, impaired left ventricle function (Ejection Fraction less than 50%) on account of any organic disease such as hypertension or valvular heart disease or serious cardiac arrhythmia requiring therapy. Patients with significant history of cardiac disease will be evaluated by the investigator or his designee.
• Patients with significant impairment of pulmonary function on account of chronic bronchitis, emphysema or chronic obstructive pulmonary disease (COPD) which has resulted in impairment of vital capacity of FEV1 to less than 75% of predicted normal values.
• Patients with symptomatic effusions on account of pleural, pericardial or peritoneal metastases of melanoma.
• Patients who are unable to return for follow-up visits as required by this study. Patients with a history of second malignant tumor, other than the common skin cancers - basal and squamous carcinomas, within the past 3 years and uncertainty about the histological nature of the metastatic lesions. Cases with other types of malignancies should be reviewed and decided by the PI of the study.
• Patients with ≥ grade 2 sensory neuropathy at baseline.
• Patients who have had major surgery or radiation therapy within 21 days of starting treatment.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Celgene: collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Melanoma

Interventions

Albumin-Bound Paclitaxel; 130-nm albumin-bound paclitaxel; Paclitaxel; Ipilimumab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Adi Diab, MD-Associate Professor, Melanoma Medical Oncology
• Organization: UT MD Anderson Cancer Center

adiab@mdanderson.org

(713) 745-7336

Study Officials

• Adi Diab, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2013
• First Posted: April 9, 2013
• Study Start: April 25, 2013
• Primary Completion: September 21, 2020
• Study Completion: September 21, 2020
• Last Updated: February 8, 2022
• Results First Posted: February 8, 2022

Record last verified: 2022-01

Locations

US (1)