Phase 1 Study of IMP321 Adjuvant to Anti-PD-1 Therapy in Unresectable or Metastatic Melanoma (TACTI-mel)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02676869
Recruitment Status : Recruiting
First Posted : February 8, 2016
Last Update Posted : March 3, 2017
Prima BioMed Ltd
Information provided by (Responsible Party):
Immutep Australia Pty. Ltd.

Brief Summary:
The purpose of this study is to determine the safety, tolerability and recommended phase 2 dose of a new drug, known as IMP321, in combination with pembrolizumab when given to patients with unresectable or metastatic melanoma.

Condition or disease Intervention/treatment Phase
Stage IV Melanoma Stage III Melanoma Drug: IMP321 Drug: Pembrolizumab Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Intervention Model: Sequential Assignment
Intervention Model Description: Study is an open label, dose escalation study. The dose is escalated following the protocol-defined safety observation period of the previous cohort.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicentre, Open Label, Dose Escalation, Phase 1 Study in Patients With Unresectable or Metastatic Melanoma Receiving IMP321 (LAG-3Ig Fusion Protein) as an Adjunctive Therapy to Anti-PD-1 Therapy With Pembrolizumab
Actual Study Start Date : February 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
U.S. FDA Resources

Arm Intervention/treatment
Experimental: IMP321 dose escalation
IMP321 administered fortnightly in addition to SOC pembrolizumab.
Drug: IMP321
Single subcutaneous injections of 1 mg (cohort 1), 6 mg (cohort 2) or 30 mg (cohort 3) of IMP321 administered every 2 weeks
Drug: Pembrolizumab
Administered according to the approved label.

Primary Outcome Measures :
  1. Number of patients with treatment emergent adverse events, serious adverse events and dose limiting toxicities. [ Time Frame: From the time of inform consent form signature until 30 days after end of treatment ]

Secondary Outcome Measures :
  1. Adverse events evaluated according to the current National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v4.03) [ Time Frame: From the time of inform consent form signature until 30 days after end of treatment. ]
  2. Objective response rate according to RECIST 1.1 [ Time Frame: At 6 and 12 months ]
  3. Objective response rate according to irRC [ Time Frame: At 6 and 12 months ]
  4. Progression free survival [ Time Frame: At 6 and 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

  1. Able to give written informed consent and to comply with the protocol
  2. Histologically confirmed diagnosis of locally advanced (unresectable Stage III) or metastatic (Stage IV) melanoma
  3. Currently receiving anti-PD-1 therapy with pembrolizumab and after 3 cycles achieved asymptomatic irPD (slowly progressive, not requiring urgent intervention, and stable performance status) or sub-optimal response (irSD, irPR) as demonstrated in imaging assessments performed within 6 weeks prior to day 1 of cycle 5 of pembrolizumab.
  4. Female or male 18 years of age or above
  5. All patients with reproductive potential must agree to use effective contraception from time of study entry until at least 4 months after the last administration of study treatment.
  6. ECOG performance status 0-1
  7. Expected survival longer than three months
  8. Resolution of toxicity associated with prior or current therapy to grade < 2 (except for alopecia and transaminases in case of liver metastases)
  9. Evidence of measurable disease as defined by Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1
  10. Laboratory criteria:

    • Absolute neutrophil count > 1.5 x 109/L
    • Platelet count ≥ 100 x 109/L
    • Haemoglobin > 9 g/dL or 5.58 mmol/L
    • Serum creatinine ≤ 1.5 × ULN
    • Total bilirubin < 20 mmol/L, except for familial cholemia (Gilbert's disease)
    • Serum AST (=GOT) and ALT (=GPT) < 3 times the upper limit of normal or < 5 times upper limit of normal if liver metastases are present

Exclusion Criteria

  1. More than four prior lines of therapies for advanced or metastatic disease.
  2. Prior PD-1/PDL-1 targeted therapy
  3. Prior high-dose chemotherapy requiring hematopoietic stem cell rescue
  4. Currently receiving treatment with another investigational drug, or less than 4 weeks since ending treatment on another investigational drug
  5. Currently receiving systemic chemotherapy, targeted small molecule therapy, radiotherapy, or biological cancer therapy (other than pembrolizumab) or less than 4 weeks since completion of these therapies and first dose of study treatment
  6. History of irAEs from ipilimumab of CTCAE Grade 4 requiring steroid treatment
  7. Known cerebral or leptomeningeal metastases. (Some subjects with previously treated brain metastases may participate under specific circumstances)
  8. Women who are pregnant or lactating
  9. Serious intercurrent infection within 4 weeks prior to first dose of study treatment
  10. Evidence of severe or uncontrolled cardiac disease (NYHA III-IV) within 6 months prior to first dose of study treatment
  11. Active acute or chronic infection
  12. History or evidence of interstitial lung disease or active non-infectious pneumonitis
  13. Active auto-immune disease requiring immunosuppressive therapy
  14. HIV positivity
  15. Active hepatitis B or hepatitis C, currently treated with antiviral therapy
  16. Life threatening illness unrelated to cancer
  17. Previous malignancies within the last three years other than melanoma
  18. Any current disorder that would impede the patient's ability to provide informed consent or to comply with the protocol
  19. Continuous systemic treatment with either corticosteroids or other immunosuppressive medications within 4 weeks prior to first dose of study treatment
  20. History or evidence of severe allergic episodes and/or angioedema
  21. Any current disorder likely to modify absorption, distribution or elimination of IMP321
  22. Alcohol or substance abuse disorder
  23. Known hypersensitivity to any of the components of IMP321
  24. Unwilling or unable to follow protocol requirements
  25. In the clinical judgment of the investigator, the patient is unsuitable for participation in this study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02676869

Contact: Prima BioMed

Australia, Queensland
Royal Brisbane Womens Hospital Recruiting
Brisbane, Queensland, Australia, 4029
Princess Alexandra Hospital Recruiting
Brisbane, Queensland, Australia, 4102
Greenslopes Private Hospital Recruiting
Brisbane, Queensland, Australia, 4120
Australia, South Australia
Flinders Medical Centre Recruiting
Adelaide, South Australia, Australia, 5042
Australia, Victoria
Alfred Hospital Recruiting
Melbourne, Victoria, Australia, 3181
Australia, Western Australia
Fiona Stanley Hospital Recruiting
Perth, Western Australia, Australia, 6150
Sponsors and Collaborators
Immutep Australia Pty. Ltd.
Prima BioMed Ltd

Responsible Party: Immutep Australia Pty. Ltd. Identifier: NCT02676869     History of Changes
Other Study ID Numbers: IMP321-P012
First Posted: February 8, 2016    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Antineoplastic Agents