A Study of Subcutaneous Nivolumab + Relatlimab FDC in Previously Untreated Metastatic or Unresectable Melanoma (RELATIVITY-127)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Bristol-Myers Squibb Services Unlimited Company

Participant type

Pediatric, Patients

Age range

0-17 years, 18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

6 Jul 2023 → ongoing

Decision date (initial)

2023-03-20

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Bristol-Myers Squibb International Corporation

External identifiers

EU CT number

2022-500967-11-00

WHO UTN

U1111-1274-0193

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Therapy, Pharmacokinetic, Pharmacogenetic, Pharmacodynamic, Others

The primary objective of this study is to assess whether the amount of study drug (both nivolumab and relatlimab) in your body when given under the skin (subcutaneously) is not different compared to study drug given directly into a vein (intravenously).

Secondary objectives 1

1. The study will also evaluate if treatment when given under the skin (subcutaneously) is not worse than (not inferior) when given directly into the vein (intravenously) in reducing skin cancer from spreading. Another goal of the study is to check the safety and quality of life in people taking the drug under the skin versus given directly into a vein.

Conditions and MedDRA coding

Previously Untreated Metastatic or Unresectable Melanoma

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

Yes

IPD plan description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure- commitment.html

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Age ≥ 12 years of age. If age ≥12 to <18 years, must weigh ≥ 40 kg
2. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1/Lansky Performance Score ≥ 80% (if age ≥ 12 to < 18 years). The Performance Status/Score describes the patient’s ability to care for themselves, perform daily physical activities (eg, walking, working).
3. Confirmed Stage III (unresectable/unable to remove with surgery) or Stage IV (metastatic/spread to other parts of the body) melanoma, per American Joint Committee on Cancer (AJCC) staging system (8th edition)
4. Treatment-naive (ie, no prior systemic anticancer therapy) except for select prior adjuvant or neoadjuvant melanoma therapies if all related adverse events have returned to baseline or stabilized.
5. Measurable disease per RECIST v1.1 (a standard way to measure how well a cancer patient responds to treatment)

Exclusion criteria 10

1. Known active brain/leptomeningeal metastases (condition in which cancer cells spread from the original (primary) tumor to the meninges (thin layers of tissue that cover and protect the brain and spinal cord)
2. Brain disease treated with whole brain radiation
3. Known ocular melanoma (melanoma in or around the eye)
4. Known/suspected autoimmune disease (condition in which the body's immune system mistakes its own healthy tissues as foreign and attacks them) except for Type I diabetes mellitus, hypothyroidism (condition where the thyroid doesn't create and release enough thyroid hormone into the bloodstream slowing down the metabolism) only requiring hormone replacement therapy, certain skin disorders not requiring systemic treatment or condition not expected to recur without external trigger
5. History of myocarditis (inflammation of the heart muscle)
6. Condition requiring systemic treatment with corticosteroid (> 10 mg daily prednisone equivalent) or other immunosuppressive agent within 14 days of treatment, except for inhaled/topical steroid or adrenal hormone (hormone produced by gland that sits on top of kidney) replacement therapy in absence of active autoimmune disease
7. Cancer requiring treatment within 2 years prior to randomization/evidence of disease, except for basal/squamous cell skin cancer or non-invasive or in situ cancers that have undergone definitive treatment
8. Prior immune checkpoint inhibitor therapies, within 6 months prior to start of study treatment
9. Prior radiation therapy within 2 weeks prior to first study treatment
10. Female who are pregnant or breastfeeding

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Co-Primary: The amount of study drug in your body when given SC is not worse than IV for both nivolumab and relatlimab.

Secondary endpoints 1

1. Secondary: Percentage of participants whose disease (skin cancer) decreased (Partial response – PR) and/or disappeared (Complete response – CR) after treatment when given under the skin is not worse as compared to given into the vein.

Investigational products

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

Test 1

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Bristol-Myers Squibb Services Unlimited Company

Sponsor organisation

Bristol-Myers Squibb Services Unlimited Company

Address

Plaza 254, Blanchardstown Corporate Park 2 Blanchardstown Corporate Park 2

City

Dublin 15

Postcode

D15 T867

Country

Ireland

Scientific contact point

Organisation

Bristol-Myers Squibb Services Unlimited Company

Contact name

GSM-CT

Public contact point

Organisation

Bristol-Myers Squibb Services Unlimited Company

Contact name

GSM-CT

Third parties 13

Locations

11 EU/EEA countries · 76 investigational sites

By country

Investigational sites

Country notifications

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

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Corrective measures 1 · Art. 77 CTR

Results and documents

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

Documents 275 files

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

Application history

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