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THE IPI - Multibasket Trial in Advanced Melanoma: Prospective Clinical Phase II Multibasket Study in Melanoma Patients With Advanced Disease (DeCOG MM-PAL11)

Phase 2
18 Years
Open (Enrolling)
Ocular Melanoma

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Trial Information

THE IPI - Multibasket Trial in Advanced Melanoma: Prospective Clinical Phase II Multibasket Study in Melanoma Patients With Advanced Disease (DeCOG MM-PAL11)


Treatment with the anti-CTLA-4 mAb Ipilimumab monotherapy of each patient in the scope of
this trial is defined as induction plus re-induction of eligible patients until 12 months
after first receipt of study medication

Induction phase:

Ipilimumab will be applied to melanoma patients according to the protocol of the completed
Medarex study MDX-010-20: Ipilimumab by IV infusion, 3 mg/kg, day 1 (Week 1), 22 (Week 4),
43 (Week 7), 64 (Week 10)


Patients who progress following stable disease of ≥ 3 months duration starting from
diagnosis at week 12 tumor assessment or patients who have progressed following an initial
response (partial or complete) assessed at week 12 may be offered additional cycles of
therapy with the originally assigned treatment regimen until off-treatment criteria are met,
provided they meet re-treatment eligibility requirements. No patient will be re-treated if
they experience a Grade 3 or higher gastrointestinal or certain other immune-related adverse
events (irAE) (refer to section 5.2 and 5.3). No patient with disease progression following
the first cycle of study medication will be permitted to be re-treated with study


The disease will be assessed at baseline, after 12 weeks and for patients with stable
disease or better responses, thereafter every 12 weeks in the absence of PD with a maximum
of one year. Response evaluation will be done according to immune-related response criteria
(Wolchok et al., CCR 2009).

All patients who prematurely discontinued treatment due to a drug-related adverse event
prior to Week 12 (in the absence of disease progression) will return for all study visits
and procedures including Week 12 and, if appropriate, further re-staging assessments. Any
patient with documented progression at any scheduled re-staging visit and who will not
receive any re-induction will undergo no further re-staging visits.

Follow-up phase:

Survival will be assessed every 3 months after the final dose of Ipilimumab until the end of
the follow-up phase for the individual patient. FU phase for each subject is 1 year
following first treatment dose. End of study will be at recruitment finished plus 1 year
post start of treatment of last patient thus ensuring that 1 year survival rate can be

Study duration:

End of study is 1 year post LPFV. Recruiting period for the ocular melanoma:

Period of recruiting 12-18 months Enrolment start date (FPI): QIII 2011 Enrolment finish
date (LPI): QI 2013 End of study: QI 2014

Inclusion Criteria

Inclusion Criteria

Patients meeting all of the following criteria will be considered for admission to the

1. Histologically proven ocular melanoma

2. Measurable disease according to RECIST in unresectable stage III-IV

3. Minimum age of 18 years,

4. Able and willing to give valid written inform consent

5. Patients with or without prior systemic treatment for advanced malignant melanoma are
eligible .

6. In case of systemic pre-treatment, an interval of at least 28 days since treatment
with chemotherapy, biochemotherapy, surgery, radiation, or immunotherapy is mandatory
as well as recovery from any clinically significant toxicity experienced during
treatment is recommended. Prior treatment must be completed by the time of ipilimumab
administration. Palliative radiation therapy outside of the brain or therapeutic
radiation to the brain after the patient's condition is stabilized and systemic
steroids required for the management of symptoms due to brain metastases is decreased
to the lowest fixed dose possible and does not require the 28-day waiting period.
Patient must have recovered from any acute toxicity associated with prior therapy.

7. Expected survival of at least six months

8. ECOG Performance Status 0, 1 or 2.

9. Within the last 2 weeks prior to study day 1 the following laboratory parameters,
which should be within the ranges specified:

Lab Parameter Range White blood cells (WBC) >= 2500/mm3 (≥ 1 2.5 x 109/L) Absolute
neutrophil count (ANC) >= 1000/mm3 (≥ 1.0 x 109/L) Platelets ≥75.000/mm3 (≥ 75 x
109/L) Hemoglobin ≥ 9 g/dL (≥ 90 g/L; may be transfused) Creatinine <= 2.0 x ULN
Bilirubin total <= 2.0 x ULN (excepted patients with Gilbert's Syndrome, who must
have a total bilirubin less than 3.0 mg/dL) <= 5 x ULN for patients with liver

10. No childbearing potential or negative pregnancy test of women of childbearing
potential performed within 7 days prior to the start of treatment.

Women of childbearing potential (WOCP) must be using an effective method of contraception
(Pearl-Index < 1, e.g. oral contraceptives, other hormonal contraceptives [vaginal
products, skin patches, or implanted or injectable products], or mechanical products such
as an intrauterine device or barrier methods [diaphragm, spermicides]) 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.

No men of fathering potential or men of fathering potential must be using an effective
method of contraception to avoid conception 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.

Women who are using oral contraceptives, other hormonal contraceptives (vaginal products,
skin patches, or implanted or injectable products), or mechanical products such as an
intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent
pregnancy, or are practicing abstinence or where their partner is sterile (eg, vasectomy)
should be considered to be of childbearing potential.

WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or
equivalent units of HCG) at Baseline within 7 days before the start of ipilimumab and at
week 12.

Exclusion Criteria

Patients will be excluded from the study for any of the following reasons:

1. The patient requires concomitant therapy with any of the following: IL 2, interferon,
or other non-study immunotherapy regimens; cytotoxic chemotherapy; immunosuppressive
agents; other investigation therapies; any other systemic therapy for cancer
including any other experimental treatment.

2. The patient requires chronic use of systemic corticosteroids. Systemic steroids for
management of symptoms due to brain mets should be avoided if possible or subject
should be stable on the lowest clinically effective dose. Topical or inhalational
steroids are permitted.

3. Use of any investigational or non-registered product (drug or vaccine) other than the
study treatment.

4. Active 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).

5. Symptomatic CNS metastases (Remark: Asymptomatic stable, untreated or pretreated
central nervous system (CNS) metastasis are allowed)

6. Family history of congenital or hereditary immunodeficiency.

7. The patient is known to be positive for Human Immunodeficiency Virus (HIV) or other
chronic infections (HBV, HCV) or has another confirmed or suspected immunosuppressive
or immunodeficient condition.

8. The patient has psychiatric or addictive disorders that may compromise his/her
ability to give informed consent or to comply with the trial procedures.

9. Lack of availability for clinical follow-up assessments.

10. The patient has concurrent severe medical problems, unrelated to the malignancy, that
would significantly limit full compliance with the study or expose the patient to
unacceptable risk.

11. Other serious illnesses, e.g., serious infections requiring antibiotics or bleeding

12. Patients with serious intercurrent illness, requiring hospitalization.

13. For female patients: the patient is pregnant or lactating. Women of childbearing
potential: Refusal or inability to use effective means of contraception

14. 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.

15. Subjects with melanoma who have another active, concurrent, malignant disease are not
eligible for this trial, with the exception of adequately treated basal or squamous
cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix.

16. Previous treatment with ipilimumab

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Description:

Overall survival rate at 12 months defined as the rate of patients alive 12 months after the date from the first study treatment for complete study

Outcome Time Frame:

alive 12 months after date from the first study drug adminstration

Safety Issue:


Principal Investigator

Dirk Schadendorf, Professor

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital, Essen


Germany: Federal Institute for Drugs and Medical Devices

Study ID:




Start Date:

October 2011

Completion Date:

September 2013

Related Keywords:

  • Ocular Melanoma
  • advanced ocular melanoma
  • Melanoma