Safety and Efficacy of IMCgp100 Versus Investigator Choice in Advanced Uveal Melanoma

Not Recruiting

Trial ID: NCT03070392


To evaluate the overall survival of HLA-A*0201 positive adult patients with previously untreated advanced UM receiving IMCgp100 compared to Investigator's Choice of dacarbazine, ipilimumab, or pembrolizumab.

Official Title

A Phase II Randomized, Open-label, Multi-center Study of the Safety and Efficacy of IMCgp100 Compared With Investigator Choice in HLA-A*0201 Positive Patients With Previously Untreated Advanced Uveal Melanoma

Stanford Investigator(s)

Sunil Arani Reddy
Sunil Arani Reddy

Clinical Associate Professor, Medicine - Oncology


Inclusion Criteria

   1. Male or female patients age ≥ 18 years of age at the time of informed consent

   2. Ability to provide and understand written informed consent prior to any study

   3. Histologically or cytologically confirmed metastatic UM

   4. Must meet the following criteria related to prior treatment:

      - No prior systemic therapy in the metastatic or advanced setting including
      chemotherapy, immunotherapy, or targeted therapy

      - No prior regional, liver-directed therapy including chemotherapy, radiotherapy,
      or embolization

      - Prior surgical resection of oligometastatic disease is allowed

      - Prior neoadjuvant or adjuvant therapy is allowed provided administered in the
      curative setting in patients with localized disease. Patients may not be
      re-treated with an Investigator's Choice therapy that was administered as
      adjuvant or neoadjuvant treatment. Additionally, patients who have received
      nivolumab as prior adjuvant/neoadjuvant treatment should not receive
      pembrolizumab as Investigator's Choice therapy.

   5. HLA A*0201 positive by central assay

   6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 at Screening

   7. Patients have measurable disease or non-measurable disease according to RECIST v1.1

   8. All other relevant medical conditions must be well-managed and stable, in the opinion
   of the investigator, for at least 28 days prior to first administration of study drug

Exclusion Criteria

   1. Out-of-range laboratory values

   2. History of severe hypersensitivity reactions (eg, anaphylaxis) to other biologic drugs
   or monoclonal antibodies

   3. Clinically significant cardiac disease or impaired cardiac function,

   4. Presence of symptomatic or untreated central nervous system (CNS) metastases, or CNS
   metastases that require doses of corticosteroids within the prior 3 weeks to study Day
   1. Patients with brain metastases are eligible if lesions have been treated with
   localized therapy and there is no evidence of PD for at least 4 weeks by magnetic
   resonance imaging (MRI) prior to the first dose of study drug

   5. Active infection requiring systemic antibiotic therapy. Patients requiring systemic
   antibiotics for infection must have completed therapy at least 1 week prior to the
   first dose of study drug

   6. Known history of human immunodeficiency virus infection (HIV). Testing for HIV status
   is not necessary unless clinically indicated

   7. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection per institutional
   protocol. Testing for HBV or HCV status is not necessary unless clinically indicated
   or the patient has a history of HBV or HCV infection

   8. Malignant disease, other than that being treated in this study. Exceptions to this
   exclusion include the following: malignancies that were treated curatively and have
   not recurred within 2 years prior to study treatment; completely resected basal cell
   and squamous cell skin cancers; any malignancy considered to be indolent and that has
   never required therapy; and completely resected carcinoma in situ of any type

   9. Any medical condition that would, in the investigator's or Sponsor's judgment, prevent
   the patient's participation in the clinical study due to safety concerns, compliance
   with clinical study procedures or interpretation of study results

10. Patients receiving systemic steroid therapy or any other systemic immunosuppressive
   medication at any dose level, as these may interfere with the mechanism of action of
   study treatment. Local steroid therapies (eg, otic, ophthalmic, intra-articular, or
   inhaled medications) are acceptable

11. History of adrenal insufficiency

12. History of interstitial lung disease

13. History of pneumonitis that required corticosteroid treatment or current pneumonitis

14. History of colitis or inflammatory bowel disease

15. Major surgery within 2 weeks of the first dose of study drug (minimally invasive
   procedures such as bronchoscopy, tumor biopsy, insertion of a central venous access
   device, and insertion of a feeding tube are not considered major surgery and are not

16. Radiotherapy within 2 weeks of the first dose of study drug, with the exception of
   palliative radiotherapy to a limited field, such as for the treatment of bone pain or
   a focally painful tumor mass

17. Use of hematopoietic colony-stimulating growth factors (eg, G-CSF, GM-CSF, M-CSF) ≤ 2
   weeks prior to start of study drug. An erythroid-stimulating agent is allowed as long
   as it was initiated at least 2 weeks prior to the first dose of study treatment and
   the patient is not red blood cell transfusion dependent

18. Pregnant, likely to become pregnant, or lactating women (where pregnancy is defined as
   the state of a female after conception and until the termination of gestation)

19. Women of childbearing potential who are sexually active with a non-sterilized male
   partner, defined as all women physiologically capable of becoming pregnant, unless
   they are using highly effective contraception during study treatment (defined in
   Section 6.7), and must agree to continue using such precautions for 6 months after the
   final dose of investigational product; cessation of birth control after this point
   should be discussed with a responsible physician. Highly effective methods of
   contraception are described in Section 6.7

20. Male patients must be surgically sterile or use double barrier contraception methods
   from enrollment through treatment and for 6 months following administration of the
   last dose of study drug

21. Patients who are in an institution due to official or judicial order.

22. Patients who are the investigator or any subinvestigator, research assistant,
   pharmacist, study coordinator, or other staff thereof, directly involved in the
   conduct of the study.

23. Contraindication for treatment with Investigator's Choice alternatives (dacarbazine,
   ipilimumab and pembrolizumab) as per applicable labelling. Patient may have a
   contraindication to 1 or 2 of the choices if he/she is a candidate for dosing with at
   least 1 Investigator's Choice and meets all other study eligibility criteria.


biological: IMCgp100

drug: Dacarbazine

biological: Ipilimumab

biological: Pembrolizumab

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Phuong Pham

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