A Study to Evaluate ABP 206 Compared with OPDIVO® (Nivolumab) in Subjects with Unresectable or Metastatic Melanoma

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Amgen Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

26 Jan 2024 → ongoing

Decision date (initial)

2023-12-04

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Amgen Inc.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Others, Pharmacokinetic, Efficacy

To assess the efficacy of ABP 206 compared with nivolumab in subjects with unresectable or metastatic melanoma who received no prior systemic treatment for advanced disease

Secondary objectives 1

1. To assess the safety and immunogenicity of ABP 206 compared with nivolumab in subjects with unresectable or metastatic melanoma who received no prior systemic treatment for advanced disease

Conditions and MedDRA coding

Unresectable or Metastatic Melanoma

Study design 1 period

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

Yes

IPD plan description

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. Subject is male or female and is ≥ 18 years of age inclusive, at the time of screening.
2. Subject must have histologically confirmed stage III (unresectable) or stage IV melanoma as per AJCC (7th edition) staging system.
3. Subject must have measurable disease according to RECIST (version 1.1).
4. Tumor tissue from the resected site of disease must be available for biomarker analyses in order to be randomized.
5. Subject has no prior systemic treatment for advanced disease. Prior adjuvant and neoadjuvant melanoma therapy is permitted if it was completed at least 6 months prior to randomization. Prior palliative radiotherapy is permitted if it was completed at least 2 weeks prior to administration of investigational product.
6. For female subject (except if at least 2 years postmenopausal or surgically sterile, see Section 10.2, Appendix 2): a negative serum pregnancy test during screening and a negative urine pregnancy test at baseline.
7. Subject has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
8. Subject screening laboratory values must meet the following criteria within 14 days prior to randomization: a. White blood cell count ≥ 2000/μL b. Neutrophils ≥ 1500/μL c. Platelets ≥ 100×10³/μL d. Hemoglobin ≥ 9.0 g/dL e. Creatinine Serum creatinine ≤ 1.5 x upper limit of normal (ULN) OR creatinine clearance > 40 mL/min as determined by Cockcroft/Gault formula: Male subject: CrCL (mL/min) = weight (kg) × (140 – age)/(72 × serum creatinine [mg/dL]) Female subject: CrCL (mL/min) = weight (kg) × (140 – age)/(72 × serum creatinine [mg/dL]) × 0.85 f. Aspartate aminotransferase (AST) ≤ 3 × ULN g. Alanine aminotransferase (ALT) ≤ 3 × ULN h. Total bilirubin ≤ 1.5 × ULN (except subjects with Gilbert Syndrome who must have total bilirubin < 3.0 mg/dL)
9. Subject is capable of signing an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved informed consent form (ICF) as described in Section 10.1.2, Appendix 1, before any study-specific procedures are performed.

Exclusion criteria 19

1. Subject has known hypersensitivity to monoclonal antibodies or to any of the excipients.
2. Subject has active central nervous system (CNS) metastases not previously treated Note: subjects with adequately treated CNS metastases, radiologically and clinically stable for at least 4 weeks are permitted if they are not receiving any dose of corticosteroids or if they are receiving stable or vanishing doses of corticosteroids in equivalent less than 10 mg of prednisone Note: Neurosurgery to treat CNS metastases and adjuvant radiation after the resection of CNS are allowed
3. Subject has had any prior systemic anti-cancer therapy for melanoma in the treatment of advanced or stage IV melanoma. Prior adjuvant and neoadjuvant melanoma therapy is permitted if it was completed at least 6 months prior to randomization
4. Subject has ocular melanoma
5. Subject has active or known immune-mediated disorders. Subjects with type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, or skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment are permitted to enroll
6. Subject has had prior treatment with PD-1/PD-L1 and cytotoxic T-lymphocyte-associated protein 4 inhibitors, or other antibodies targeting immune checkpoint pathways
7. Subject has, per the opinion of the investigator, rapidly progressing tumor and requires treatment with faster onset than immune checkpoint inhibitors
8. Subject has medical conditions requiring systemic immunosuppression with either corticosteroids (≥ 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days of the first dose of investigational product. Inhaled or topical steroids permitted in the absence of active autoimmune disease
9. Subject has any concurrent serious or uncontrolled medical condition (including active infection) that, in the opinion of the investigator, may increase the risk associated with study participation, investigational product administration, or would impair the ability of the subject to receive protocol therapy
10. Subject has received other investigational procedures within 4 weeks prior to enrollment
11. Subject has any physical or psychiatric disorder that, in the opinion of the investigator, may compromise the ability of the subject to give informed consent and/or to comply with all the required study procedures
12. Subject has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
13. Subject has undergone prior allogeneic hematopoietic stem cell transplantation within the last 5 years (subjects who had a transplant greater than 5 years ago are eligible as long as there are no symptoms of graft-versus-host disease)
14. Subject has a history of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥ 3 years before the first dose of investigational product and of low potential risk for recurrence - basal cell carcinoma of the skin, squamous cell carcinoma of the skin or lentigo maligna that has undergone potentially curative therapy, or adequately treated carcinoma in situ without evidence of disease
15. Subject has positive screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb; immunoglobulin M test only), or hepatitis C virus (HCV). Subjects with known diagnosis of HIV infection who meet the following criteria are permitted to enroll: • CD4+ T-cell counts > 350 cells/μL and without acquired immunodeficiency syndrome-defining opportunistic infections within the past 12 months. • On antiretroviral therapy for four or more weeks with a viral load of below 400 copies/mL before trial enrollment
16. Subject has live vaccine therapy within 4 weeks prior to the first dose of investigational product
17. Subject is a woman of childbearing potential (WOCBP) who is pregnant or breastfeeding or planning to become pregnant while participating in the study and for at least 5 months after the last dose of investigational product
18. Subject is a WOCBP who is not consenting to highly effective methods of birth control (eg, true abstinence, sterilization, birth control pills, Depo Provera injections, or contraceptive implants) during treatment and for an additional 5 months after the last administration of the protocol-specified treatment
19. Subject is a man with a partner of childbearing potential who does not consent to use highly effective methods of birth control (eg, true abstinence, vasectomy, or a condom in combination with hormonal birth control, or barrier methods used by the woman) during treatment and for an additional 5 months after the last administration of the protocol-specified treatment

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Objective response by week 49

Secondary endpoints 4

1. Secondary Efficacy Endpoints: • Objective response at week 17 • PFS • OS • DOR
2. Secondary Endpoints Safety-related Endpoints: • Treatment-emergent adverse events • Treatment-emergent serious adverse events • Treatment-emergent adverse events of interest
3. Secondary Endpoints Immunogenicity-related Endpoints: • Incidence of ADAs
4. Secondary Endpoints Pharmacokinetic-related Endpoints: • ABP 206 and nivolumab serum (trough) concentrations

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Amgen Inc.

Sponsor organisation

Amgen Inc.

Address

1 Amgen Center Drive

City

Thousand Oaks

Postcode

91320-1799

Country

United States

Scientific contact point

Organisation

Amgen Inc.

Contact name

Medical Information

Public contact point

Organisation

Amgen Inc.

Contact name

Medical Information

Third parties 6

Locations

12 EU/EEA countries · 73 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 151 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

26 submissions — initial application plus substantial / non-substantial modifications