Please assess the completion status of the following clinical trial:

Trial Title: CTLA-4 Blockade and Low Dose Cyclophosphamide in Patients With Advanced Malignant Melanoma

Study Design Characteristics:
- Allocation: None
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE2
- Number of Arms: 1.0

Eligibility Criteria:
Inclusion Criteria:~1. Men \& women, ages ≥18~2. Willing/able to give written informed consent.~3. Histologic diagnosis of unresectable AJCC Stage III/IV malignant melanoma~4. At least 2wks must have elapsed since last chemotherapy, immunotherapy, hormonal therapy, radiotherapy or major surgery \& beginning of protocol therapy. At least 6wks for nitrosoureas, mitomycin C, \& liposomal doxorubicin~5. Toxicity related to prior therapy must either have returned to ≤ grade 1 or baseline.~6. Two punch tumor biopsy at Screening and Wk12 (4mm diameter) must be provided for immune analysis/staining if patients have accessible disease. Biopsies are optional during the Maintenance Period.Site of tumor biopsy s/n be only site of measurable disease. Minimum of 5 out of 1st 10 patients in stage I of the protocol must have biopsy accessible disease.~7. Patients must have measurable disease defined as @ least 1 lesion that can be accurately measured in @ least 1 dimension (longest diameter to be recorded) as \>20 mm with conventional techniques or as \>10 mm with spiral CT scan.~8. Required values for initial laboratory tests:~   1. WBC ≥ 2000/uL~  2. ANC ≥ 1000/uL~  3. Platelets ≥ 50 x 103/uL~  4. Hemoglobin ≥ 9.5 g/dL~  5. Creatinine ≤ 3.0 x ULN~  6. AST/ALT ≤ 2.5 x ULN for patients without liver metastasis, ≤ 5 x ULN for patients with liver metastasis~  7. Bilirubin ≤ 3.0 x ULN, (except patients with Gilbert's Syndrome, who must have a total bilirubin less than 3.0 mg/dL)~9. Life expectancy of at least 4mos~10. Patients w/stable, treated central nervous system (CNS) metastasis are eligible~11. ECOG Performance Status Score 0-1~12. Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout study \& for up to 26wks 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 w/o another cause, or~   * For women with irregular menstrual periods and taking hormone replacement therapy (HRT), documented serum follicle-stimulating hormone (FSH) level ≥ 35 mIU/mL.~   * Women who are using oral contraceptives, other hormonal contraceptives (vaginal products/skin patches/implanted/injectable products), mechanical products such as an intrauterine device or barrier methods (diaphragm/condoms/ spermicides) to prevent pregnancy,are practicing abstinence or where their partner is sterile (eg vasectomy) should be considered to be of childbearing potential.~   * WOCBP must have a negative urine or serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) w/in 72hrs before the start of ipilimumab.~13. Men of fathering potential must be using an adequate method of contraception to avoid conception throughout the study \[and up to 26wks after last dose of investigational product\] in a way that risk of pregnancy is minimized.~Exclusion Criteria:~1. Any other malignancy from which patient has been disease-free for less than 5yrs, with the exception of adequately treated \& cured basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix.~2. 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 (eg Guillain-Barre Syndrome and Myasthenia Gravis).~3. Any underlying medical or psychiatric condition, which in the opinion of investigator will make administration of ipilimumab hazardous or obscure interpretation of AEs, like a condition associated with frequent diarrhea.~4. Uncontrolled or significant cardiovascular disease~5. Any non-oncology vaccine therapy used for prevention of infectious diseases (for up to 1mo before/after any dose of ipilimumab).~6. History of prior treatment with ipilimumab or prior CD137 agonist or CTLA 4 inhibitor or agonist.~7. Concomitant therapy with any of following: IL 2, interferon, other non-study immunotherapy regimens; immunosuppressive agents; other investigation therapies; or chronic use of systemic corticosteroids (\>60mg prednisone/day).~8. Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (eg infectious) illness.~9. Women of childbearing potential (WOCBP), defined above who:~   1. are unwilling/unable to use an acceptable method of contraception to avoid pregnancy for their entire study period and for at least 26wks after cessation of study drug, or~  2. have a positive pregnancy test at baseline, or~  3. are pregnant or breastfeeding.~10. Persons of reproductive potential who are unwilling to use an adequate method of contraception throughout treatment \& for at least 26wks after ipilimumab is stopped.

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Cyclophosphamide, Ipilimumab (Type: EXPERIMENTAL): Treatment:~Cyclophosphamide 300 mg/m2 po - Day 1 of Weeks 1, 4, 7, and 10, for a total of 4 doses; (premedication prior to each dose of Cyclophosphamide 8mg Zofran po, then prn)~Ipilimumab 10 mg/kg iv - Day 3 of Weeks 1, 4, 7, and 10 for a total of 4 doses Maintenance treatment will be given on Weeks 24, 36, and 48 Ipilimumab 10 mg/kg iv

Based on this trial design, predict the completion outcome and termination type (if applicable).

Answer: outcome: terminate
termination_type: lack of efficacy