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Phase 1
18 Years
Open (Enrolling)

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Trial Information

Inclusion Criteria:

- Must be able to provide informed consent

- In Dose-Escalation: Must have solid tumor malignancy or cutaneous T-cell lymphoma
that has relapsed and is refractory to standard therapy, or for which no standard
therapy exists

- In Expansion Phase: Must have melanoma or ovarian cancer that is histologically or
cytologically confirmed

- Ovarian cancer patients must have recurrent of persistent non-mucinous disease, and
must not have received more than 2 prior chemotherapeutic regimens

- Melanoma patients must have recurrent or persistent non-ocular AJCC Stage IIIC or IV
disease that is surgically incurable and unresectable

- Melanoma patients with documented BRAF mutation that is known to be responsive to
BRAF inhibitors must have failed or be intolerant to such inhibitors

- Must have measurable disease

- Must be able to provide access to archival (Dose-Escalation Phase) and/or fresh tumor
tissue (Dose-Escalation and Expansion Phases) at Screening prior to study entry

- Must by at least 18 years old

- Must have adequate organ function

Exclusion Criteria:

- Prior cancer therapies must have completed at least 14 days or 5 half-lives
(whichever is longer) prior to first dose of AMP-224

- Prior treatment with an anti-PD1 antibody therapy

- Known antibody response against prior antibody therapy or fusion protein therapeutics

- Major surgery within 4 weeks prior to first dose of AMP-224

- Prior allogeneic or autologous bone marrow or organ transplantation

- Known and/or a history or evidence of autoimmune disease except vitiligo, resolved
childhood asthma and stable hypothyroidism

- Received an immunomodulatory drug within 2 weeks of first dose of AMP-224

- Active infections requiring antibiotics, physician monitoring, or recurrent fevers
>100.4 degrees fahrenheit associated with a clinical diagnosis of active infection

- Patients with cirrhosis

- Clinically significant cardiac or electrocardiogram abnormalities

- History or evidence of HIV

- Active viral disease (except when the viral infection is associated with the

- Regular use of illicit drugs or a recent history of substance abuse

- Pregnant or breastfeeding women

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of participants with adverse events.

Outcome Time Frame:

From start of study drug administration until the date of first documented progression or date of death from any cause; through Day 56 of final cycle.

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

March 2011

Completion Date:

Related Keywords:

  • Cancer
  • Cancer
  • Carcinoma
  • Tumor
  • Solid tumor
  • Metastatic
  • Melanoma



Memorial Sloan Kettering Cancer Center New York, New York  10021
Karmanos Cancer Institute Detroit, Michigan  48201
Carolina BioOncology Institute Huntersville, North Carolina  28078
Sarah Cannon Research Institute Nashville, Tennessee  37203