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Carcinoma, HepatocellularPhase 1/2RELATIVITY-106NCT05337137

A Study of Nivolumab and Relatlimab in Combination With Bevacizumab in Advanced Liver Cancer

A Phase 1/2 study testing Relatlimab, Nivolumab and Bevacizumab in people with Carcinoma, Hepatocellular, run by Bristol-Myers Squibb at 61 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate the safety and effectiveness of triplet therapy of nivolumab, relatlimab and bevacizumab versus nivolumab and bevacizumab in participants with untreated advanced/metastatic hepatocellular carcinoma (HCC). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Hepatocellular
What is being tested?
Relatlimab, Nivolumab and Bevacizumab
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
82 participants
Where
61 sitesin 15 countries
Study dates
5 May 2022to 18 Nov 2025
Phase
Phase 1/2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed advanced/metastatic hepatocellular carcinoma (HCC)
  • Naïve to systemic therapy for advanced/metastatic HCC (prior neo-adjuvant or adjuvant immunotherapy is permitted if recurrence occurs ≥ 6 months after treatment completion and the case is discussed with BMS medical team)
  • Child-Pugh score of 5 or 6 (ie, Child-Pugh A)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Who cannot join

  • Known fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC
  • Prior allogenic stem cell or solid organ transplantation
  • Untreated symptomatic central nervous system (CNS) metastases
  • Clinically significant ascites as defined by:
  • Prior ascites that required treatment and requires on-going prophylaxis, or ii) Current ascites requiring treatment
  • Other protocol-defined inclusion/exclusion criteria apply

Trial locations and contacts

61 sites in 15 countries.

61 sites in 15 countries

United States10 sites

  • Local Institution - 0059

    Baltimore, Maryland, 21231

  • Local Institution - 0060

    Boston, Massachusetts, 02114

  • Local Institution - 0065

    Boston, Massachusetts, 02215

  • Local Institution - 0042

    Los Angeles, California, 90033

  • Local Institution - 0039

    Los Angeles, California, 90095

  • Local Institution - 0033

    Milwaukee, Wisconsin, 53226

  • Local Institution - 0061

    New York, New York, 10065

  • Local Institution - 0034

    San Francisco, California, 94115

  • Local Institution - 0062

    The Bronx, New York, 10461

  • Local Institution - 0030

    Washington D.C., District of Columbia, 20007

Other trials in United States

France6 sites

  • Local Institution - 0021

    Avignon, Cedex 9, 84918

  • Local Institution - 0012

    Grenoble, 38043

  • Local Institution - 0001

    Nice, 06202

  • Local Institution - 0002

    Reims, 51092

  • Local Institution - 0008

    Rennes, 35042

  • Local Institution - 0054

    Suresnes, 92151

Other trials in France

Japan6 sites

  • Local Institution - 0063

    Chuo-ku, Tokyo, 104-0045

  • Local Institution - 0058

    Kanazawa, Ishikawa-ken, 9208641

  • Local Institution - 0047

    Kashiwa-shi, Chiba, 2778577

  • Local Institution - 0048

    Matsuyama, Ehime, 7900024

  • Local Institution - 0041

    Sayama, Osaka, 5898511

  • Local Institution - 0050

    Yokohama, Kanagawa, 2320024

Other trials in Japan

Spain6 sites

  • Local Institution - 0067

    Madrid, Sede Madrid, 28027

  • Local Institution - 0053

    Madrid, 28046

  • Local Institution - 0038

    Pamplona, 31008

  • Local Institution - 0007

    Santander, Cantabria, 39008

  • Local Institution - 0032

    Santiago de Compostela, A Coruña, 15706

  • Local Institution - 0040

    Zaragoza, 50009

Other trials in Spain

Australia5 sites

  • Local Institution - 0022

    Adelaide, South Australia, 5000

  • Local Institution - 0045

    Camperdown, New South Wales, 2050

  • Local Institution - 0026

    Heidelberg, Victoria, 3084

  • Local Institution - 0013

    Melbourne, Victoria, 3065

  • Local Institution - 0017

    Nedlands, Western Australia, 6009

Other trials in Australia

Germany4 sites

  • Local Institution - 0051

    Düsseldorf, North Rhine-Westphalia, 40225

  • Local Institution - 0035

    Frankfurt, 60590

  • Local Institution - 0057

    Mainz, 55131

  • Local Institution - 0055

    Munich, 81377

Other trials in Germany

Singapore4 sites

  • Local Institution - 0029

    Singapore, 168583

  • Local Institution - 0027

    Singapore, 217562

  • Local Institution - 0018

    Singapore, 308433

  • Local Institution - 0044

    Singapore, 329563

Other trials in Singapore

Taiwan4 sites

  • Local Institution - 0043

    District Taichung City, Tai Zhong Shi, 404

  • Local Institution - 0024

    Taichung, 40705

  • Local Institution - 0046

    Taipei, 10048

  • Local Institution - 0049

    Taipei, 11217

Other trials in Taiwan

Italy3 sites

  • Local Institution - 0036

    Milan, 20122

  • Local Institution - 0003

    Padova, 35128

  • Local Institution - 0010

    Roma, 00168

Other trials in Italy

Poland3 sites

  • Local Institution - 0028

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796

  • Local Institution - 0023

    Gdansk, 80-219

  • Local Institution - 0016

    Warsaw, Masovian Voivodeship, 02-034

Other trials in Poland

Canada2 sites

  • Local Institution - 0025

    Edmonton, Alberta, T6G 1Z2

  • Local Institution - 0009

    Toronto, Ontario, M5G 2M9

Other trials in Canada

China2 sites

  • Local Institution - 0064

    Guangzhou, Guangdong, 510515

  • Local Institution - 0066

    Xi'an, Shan3xi, 710700

Other trials in China

Hong Kong2 sites

  • Local Institution - 0004

    Hong Kong, 0

  • Local Institution - 0031

    Shatin, 999077

Other trials in Hong Kong

Puerto Rico2 sites

  • Local Institution - 0052

    Rio Piedras, PR, 935

  • Local Institution - 0019

    San Juan, 00927

Other trials in Puerto Rico

South Korea2 sites

  • Local Institution - 0037

    Seongnam-si, Gyeonggido, 13496

  • Local Institution - 0056

    Seoul, 138-736

Other trials in South Korea

About this study

Official title: A Phase 1/2, Safety Confirmation, Placebo-controlled, Randomized Study of Nivolumab in Combination With Relatlimab and Bevacizumab in Treatment-naive Advanced/Metastatic Hepatocellular Carcinoma

The purpose of this study is to evaluate the safety and effectiveness of triplet therapy of nivolumab, relatlimab and bevacizumab versus nivolumab and bevacizumab in participants with untreated advanced/metastatic hepatocellular carcinoma (HCC).

Being tested
Relatlimab, Nivolumab, Bevacizumab, Placebo
Keywords
Hepatocellular Carcinoma, HCC, Liver Cancer, Relatlimab, Nivolumab, Bevacizumab, First line HCC
Medical subject headings
Carcinoma, Hepatocellular, Liver Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RelatlimabDrug

    Also called BMS-986016

    Specified dose on specified days

  • NivolumabDrug

    Also called BMS-936558, Opdivo

    Specified dose on specified days

  • BevacizumabDrug

    Also called Avastin

    Specified dose on specified days

  • PlaceboOther

    Specified dose on specified days

Study groups in NCT05337137
Study groupRoleWhat they receive
Arm A: Relatlimab + Nivolumab + BevacizumabExperimentalNot described
Receives: Drug: Relatlimab; Drug: Nivolumab; Drug: Bevacizumab
Arm B: Placebo + Nivolumab + BevacizumabExperimentalNot described
Receives: Drug: Nivolumab; Drug: Bevacizumab; Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Dose Limiting Toxicities

    Bevacizumab DLTs: Include any AE causing >42-day delay, GI perforation, nephrotic syndrome, Grade 3/4 infusion reactions, Death events, neutropenic fever, most non-hematologic toxicities (with specified exceptions), prolonged severe GI/electrolyte issues, significant fatigue, severe liver enzyme elevation, PRES/RPLS, severe hypertension or cardiac events, thromboembolism, major bleeding, wound complications, fistula, necrotizing fasciitis, and severe hematologic toxicity.

    Immunotherapy DLTs: Include severe immune-related events (eg, colitis, pneumonitis, uveitis), Grade 4 organ toxicities, serious hypersensitivity, prolonged/recurrent AEs, severe electrolyte/GI/fatigue events, Grade 5 events, severe hematologic, hepatic, neurologic, cardiac (myocarditis), and severe dermatologic reactions (eg, SJS/TEN, DRESS).

    Measured: From Day 1 (first dose) untill 6 weeks post first dose

  2. Objective Response Rate (ORR) Assessed by BICR - All Comer Population

    Objective response rate (ORR) is defined as the percentage of participants who achieve a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), based on blinded independent central review (BICR) assessments using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), divided by the number of all randomized participants. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

    Measured: From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 3 years)

  3. Objective Response Rate (ORR) Assessed by BICR - All EHSS No Population

    Objective response rate (ORR) is defined as the percentage of participants who achieve a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), based on blinded independent central review (BICR) assessments using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), divided by the number of all randomized participants. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

    Measured: From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 3 years)

Secondary outcomes (7)

  1. Progression-Free Survival (All Comer Population) Per BICR in Participants With LAG-3 Positive Status(≥1% by IHC)

    Progression free survival (PFS) is defined as time from on treatment to disease progression or death (whichever comes first). Disease progression is defined as Unequivocal progression of existing non-target lesions.

    Measured: From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 3 years)

  2. Progression-Free Survival (All EHSS No Population) Per BICR in Participants With LAG-3 Positive Status(≥1% by IHC)

    Progression free survival (PFS) is defined as time from on treatment to disease progression or death (whichever comes first). Disease progression is defined as unequivocal progression of existing non-target lesions.

    Measured: From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 3 years)

  3. Objective Response Rate (ORR) Per BICR - All Comer Population in Participants With LAG-3 Positive Status(≥1% by IHC)

    Objective response rate (ORR) is defined as the percentage of participants who achieve a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), based on blinded independent central review (BICR) assessments using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), divided by the number of all randomized participants. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

    Measured: From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 3 years)

  4. Objective Response Rate (ORR) Per BICR - All EHSS No Population in Participants With LAG-3 Positive Status(≥1% by IHC)

    Objective response rate (ORR) is defined as the percentage of participants who achieve a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), based on blinded independent central review (BICR) assessments using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), divided by the number of all randomized participants. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

    Measured: From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 3 years)

  5. Number of Participants With Adverse Events

    An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization.

    Measured: From first dose (Day 1) to 30 days after last dose (up to approximately 36 months)

  6. Number of Participants With Select Adverse Events

    An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.

    Measured: From first dose (Day 1) to 30 days after last dose (up to approximately 36 months)

  7. Number of Participants With Immune Mediated Endocrine Adverse Events

    An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.

    Measured: From first dose (Day 1) to 30 days after last dose (up to approximately 36 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2022
  2. Study start5 May 2022
  3. Primary completion5 Jul 2025
  4. Study completion18 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
82 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05337137
Sponsor's protocol ID
CA224-106
Other IDs
2021-003606-53, U1111-1267-1579
Acronym
RELATIVITY-106
Status last verified
Sep 2026
First submitted
13 Apr 2022
Last updated
14 Oct 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Expanded access
Available

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