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A Study to Assess the Safety and Efficacy of Intratumoral IMO-2125 in Combination With Ipilimumab or Pembrolizumab in Patients With Metastatic Melanoma

NCT02644967

Description:

The goal of this clinical research study is to find the recommended dose of the study drug IMO-2125 that can be given in combination with ipilimumab or in combination with pembrolizumab to patients with metastatic melanoma. Researchers also want to learn if the study drug combination can help to control the disease. The safety of the drug combination will also be studied.

Related Conditions:
  • Melanoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study to Assess the Safety and Efficacy of Intratumoral IMO-2125 in Combination With Ipilimumab or Pembrolizumab in Patients With Metastatic Melanoma
  • Official Title: A Phase 1/2 Study to Assess the Safety and Efficacy of Intratumoral IMO-2125 in Combination With Ipilimumab or Pembrolizumab in Patients With Metastatic Melanoma

Clinical Trial IDs

  • ORG STUDY ID: 2125-204
  • NCT ID: NCT02644967

Conditions

  • Metastatic Melanoma

Interventions

DrugSynonymsArms
IMO-2125Arm 1
IpilimumabYervoy®Arm 1
PembrolizumabKeytruda®Arm 2

Purpose

The goal of this clinical research study is to find the highest tolerated dose of the study drug IMO-2125 that can be given in combination with ipilimumab or in combination with pembrolizumab to patients with metastatic melanoma. Researchers also want to learn if the study drug combination can help to control the disease. The safety of the drug combination will also be studied.

Detailed Description

      This is an open-label Phase 1/2 study to determine the maximum tolerated dose (MTD) and
      assess the safety, tolerability, pharmacokinetics (PK), immunogenicity, and efficacy of
      IMO-2125 when administered in combination with ipilimumab or pembrolizumab. The study will
      be conducted in 2 parts; a dose-escalation portion (Phase 1) to evaluate safety and
      tolerability of multiple dose levels and a Phase 2 portion to assess efficacy.
    

Trial Arms

NameTypeDescriptionInterventions
Arm 1ExperimentalIMO-2125 intratumoral injection plus ipilimumab
  • IMO-2125
  • Ipilimumab
Arm 2ExperimentalIMO-2125 intratumoral injection plus pembrolizumab
  • IMO-2125
  • Pembrolizumab

Eligibility Criteria

        Inclusion Criteria:

          -  Patients must have histologically confirmed metastatic melanoma with measurable,
             stage III (lymph node or in transit lesions) or stage IVA, IVB, or IVC disease.

          -  Patients must have symptomatic or radiographic confirmed progression after treatment
             with a PD-1 inhibitor administered either as monotherapy or in combination (except
             for ipilimumab or other CTLA-4 inhibitor combination).

               1. The interval between last PD-1 directed treatment and start of study treatment
                  should be at least 21 days.

               2. No intervening anti-cancer therapy between the last course of anti-PD-1
                  containing treatment and the first dose of study treatment is allowed except for
                  local measures (e.g., surgical excision or biopsy, focal RT).

               3. Prior adjuvant ipilimumab is acceptable.

               4. Prior BRAF or MEK inhibitor treatment is not required.

               5. Previous treatment with either a PD-1 or CTLA-4 inhibitor (if applicable) should
                  not have been accompanied DLT for which permanent discontinuation is recommended
                  (per USPI).

          -  Patients must have at least two measurable tumor lesions ≥ 1.0 cm that are accessible
             to biopsy.

          -  Patients must be ≥ 18 years of age.

          -  Patients must have Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2.

          -  Patients must meet the following laboratory criteria:

               -  Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L (1500/mm3)

               -  Platelet count ≥ 100 x 10^9/L (100,000/mm3)

               -  Hemoglobin ≥ 8.0 g/dL (4.96 mmol/L)

               -  Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or 24-hour creatinine
                  clearance ≥ 60 mL/minute

               -  Aspartate aminotransferase (AST) ≤ 2.5 x ULN; alanine aminotransferase (ALT) ≤
                  2.5 x ULN; AST/ALT < 5 x ULN if liver involvement

               -  Serum bilirubin ≤ 1.5 x ULN, except in patients with Gilbert's Syndrome who must
                  have a total bilirubin < 3 mg/dL

          -  Women of childbearing potential (WOCBP) and men must agree to use effective
             contraceptive methods from Screening throughout the study treatment period and until
             at least 3 months after the last dose of ipilimumab or at least 4 months after the
             last dose of pembrolizumab.

          -  Patients must have an anticipated life expectancy > 3 months.

        Exclusion Criteria:

          -  Patients who have received prior therapy with a TLR agonist ,excluding topical
             agents. Patients who have received experimental vaccines or other immune therapies
             should be discussed with the Medical Monitor to confirm eligibility.

          -  Patients who have received systemic treatment with IFN-α within the previous 6 months
             prior to enrolling into this study.

          -  Patients with known hypersensitivity to any oligodeoxynucleotide.

          -  Patients with active autoimmune disease requiring disease modifying therapy.

          -  Patients requiring concurrent systemic steroid therapy higher than physiologic dose
             (7.5 mg/day of prednisone).

          -  Patients with any form of active primary or secondary immunodeficiency.

          -  Patients with another primary malignancy that has not been in remission for at least
             3 years.

          -  Patients with active systemic infections requiring antibiotics or active hepatitis A,
             B, or C.

          -  Patients with a known diagnosis of human immunodeficiency virus (HIV) infection.

          -  Patients with known central nervous system, meningeal, or epidural disease. Patients
             with stable brain metastases following definitive local treatment are eligible if
             steroid requirement is less than 7.5 mg/day of prednisone (or equivalent).

          -  Women who are pregnant or breastfeeding.

          -  Patients with impaired cardiac function or clinically significant cardiac disease.

          -  Patients with ocular melanoma.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Phase 1: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 to determine the recommended Phase 2 dose of IMO-2125.
Time Frame:13 weeks (13 weeks of treatment, 4 weeks follow up)
Safety Issue:
Description:

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Idera Pharmaceuticals, Inc.

Last Updated

March 1, 2017