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An Open-Label, Dose-Escalation Phase 1/1b Study of the Anti-gp75 Monoclonal Antibody IMC-20D7S In Patients With Malignant Melanoma Who Have Progressed After or During at Least One Treatment With Standard Cytotoxic Treatment or/and Immunotherapy Therapy or For Whom Standard Therapy is Not Indicated


Phase 1
18 Years
N/A
Not Enrolling
Both
Malignant Melanoma

Thank you

Trial Information

An Open-Label, Dose-Escalation Phase 1/1b Study of the Anti-gp75 Monoclonal Antibody IMC-20D7S In Patients With Malignant Melanoma Who Have Progressed After or During at Least One Treatment With Standard Cytotoxic Treatment or/and Immunotherapy Therapy or For Whom Standard Therapy is Not Indicated


Inclusion Criteria:



- Patient has histologically or cytologically confirmed cutaneous, mucosal, or uveal
malignant melanoma which has progressed after or during at least 1 treatment with
standard cytotoxic treatment or/and immunotherapy (eg, treatment with cytokines,
monoclonal antibodies, and vaccines) and is not regarded to be a candidate for a
potentially curative, higher priority treatment for melanoma

- Patient is ≥ 18 years of age

- Patient has either measurable disease as defined by RECIST 1.1 or evaluable disease

- At least 21 days must have elapsed from major surgery, prior chemotherapy, prior
treatment with an investigational agent or device, or prior radiation therapy.
Relative to patient's treatment with non-approved biological products (eg, monoclonal
antibodies), a minimum of 2 half-lives must have passed for eligibility to be
considered

- Patient has resolution of all clinically significant toxic effects of prior cancer
therapy to Grade ≤ 1 according to National Cancer Institute Common Terminology
Criteria for Adverse Events (NCI-CTCAE) Version 4.02

- Patient has adequate hematological function, hepatic function, and renal function

Exclusion Criteria:

- Patient has undergone major surgery (eg, laparotomy, thoracotomy, removal of
organ[s]) within 21 days prior to study entry

- Patient has elective or planned surgery to be conducted during the trial

- Patient has documented and/or symptomatic brain or leptomeningeal metastases

- Patient is receiving systemic steroids or other immunosuppressive
medications.(Intermittent use of steroid-containing medications, eg, for asthma
exacerbation or for skin lesions, is permitted)

- Patient has an uncontrolled undercurrent illness

- Patient has a concurrent active malignancy other than adequately treated
nonmelanomatous skin cancer or other noninvasive carcinoma or in situ neoplasm

- Patient has a known allergy to any of the treatment components (monoclonal antibodies
or other therapeutic proteins such as fresh frozen plasma, human serum albumin,
cytokines, or interleukins). In the event that there is suspicion the patient may
have allergies, the patient should be excluded

- Patient is pregnant or lactating

- Patient has known HIV or AIDS infection

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose (MTD)

Outcome Description:

The MTD population will include all patients who complete Cycle 1, die during Cycle 1, or discontinue due to a DLT. Patients who do not complete Cycle 1 for reasons other than a DLT will be replaced.

Outcome Time Frame:

22 months

Safety Issue:

Yes

Principal Investigator

E-mail: ClinicalTrials@ ImClone.com

Investigator Role:

Study Director

Investigator Affiliation:

ImClone LLC

Authority:

United States: Food and Drug Administration

Study ID:

13945

NCT ID:

NCT01137006

Start Date:

June 2010

Completion Date:

August 2012

Related Keywords:

  • Malignant Melanoma
  • Melanoma
  • Phase I
  • antibody
  • melanin
  • tyrosinase related protein 1
  • glycoprotein
  • 20D7S
  • Melanoma

Name

Location

ImClone Investigational SiteNew York, New York  10021
ImClone Investigational SiteBoston, Massachusetts  02135