A Study to Assess the Safety and Tolerability of BMS-986158 Alone and in Combination With Either Ruxolitinib or Fedratinib in Participants With Blood Cancer (Myelofibrosis)

NCT04817007 | Active Not Recruiting Phase 1 FDA Drug

• 2 other identifiers: CA011-0232020-002071-35
• Study Type: interventional
• Target: 216
• Locations: 12 countries
• Sites: 53

Brief Summary

The purpose of this study is to assess the safety, tolerability, and efficacy of BMS-986158 alone and in combination with either Ruxolitinib or Fedratinib in participants with Dynamic International Prognostic Scoring System (DIPSS)-intermediate or high risk blood cancer. Part 1 consists of BMS-986158 in combination with either Ruxolitinib or Fedratinib and Part 2 consists of BMS-986158 in combination with either Ruxolitinib or Fedratinib and BMS-986158 alone.

Conditions

Myelofibrosis

Keywords

BMS-986158; Fedratinib; Myelofibrosis; Ruxolitinib

Outcome Measures

Primary Outcomes (5)

• Incidence of adverse events (AEs)

  Up to 52 months

• Incidence of serious adverse events (SAEs)

  Up to 52 months

• Incidence of AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria

  Up to 26 months

• Incidence of AEs leading to discontinuation

  Up to 52 months

• Incidence of death

  Up to 52 months

Secondary Outcomes (6)

• Spleen volume reduction (SVR) at end of Cycle 6 assessed by Blinded Independent Central Review (BICR)

  Up to 175 days

• Response rate defined as proportion of participants with SVR ≥ 35% by MRI (preferred) or CT (if MRI is contraindicated and if CT is allowed by local guidelines) assessed by BICR

  Up to 175 days

• SVR at end of Cycle 3 and 6 assessed by BICR

  Up to 175 days

• Response rate defined as proportion of participants with SVR ≥ 25% by MRI (preferred) or CT (if MRI is contraindicated and if CT is allowed by local guidelines) assessed by BICR

  Up to 175 days

• Symptom response rate (SRR) based on total symptom score (TSS) measured by Myelofibrosis Symptom Assessment Form (MFSAF)

  Up to 175 days

Study Arms (7)

Part 1A: BMS-986158 + Ruxolitinib

EXPERIMENTAL

Drug: BMS-986158; Drug: Ruxolitinib

Part 1B: BMS-986158 + Fedratinib

EXPERIMENTAL

Drug: BMS-986158; Drug: Fedratinib

Part 2A1: BMS-986158 + Ruxolitinib

EXPERIMENTAL

Drug: BMS-986158; Drug: Ruxolitinib

Part 2B1: BMS-986158 + Fedratinib

EXPERIMENTAL

Drug: BMS-986158; Drug: Fedratinib

Part 2B2: BMS-986158 Mono and/or (BMS-986158 + Fedratinib), if applicable

EXPERIMENTAL

Drug: BMS-986158; Drug: Fedratinib

Part 2A2 Add-On: BMS-986158 + Ruxolitinib

EXPERIMENTAL

Drug: BMS-986158; Drug: Ruxolitinib

Part 2A3: BMS-986158 + Ruxolitinib

EXPERIMENTAL

Drug: BMS-986158; Drug: Ruxolitinib

Interventions

Ruxolitinib DRUG

Specified dose on specified days

Also known as: Jakafi®

Part 1A: BMS-986158 + Ruxolitinib; Part 2A1: BMS-986158 + Ruxolitinib; Part 2A2 Add-On: BMS-986158 + Ruxolitinib; Part 2A3: BMS-986158 + Ruxolitinib

Fedratinib DRUG

Specified dose on specified days

Part 1B: BMS-986158 + Fedratinib; Part 2B1: BMS-986158 + Fedratinib; Part 2B2: BMS-986158 Mono and/or (BMS-986158 + Fedratinib), if applicable

BMS-986158 DRUG

Specified dose on specified days

Part 1A: BMS-986158 + Ruxolitinib; Part 1B: BMS-986158 + Fedratinib; Part 2A1: BMS-986158 + Ruxolitinib; Part 2A2 Add-On: BMS-986158 + Ruxolitinib; Part 2A3: BMS-986158 + Ruxolitinib; Part 2B1: BMS-986158 + Fedratinib; Part 2B2: BMS-986158 Mono and/or (BMS-986158 + Fedratinib), if applicable

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of primary myelofibrosis (PMF), post-essential thrombocythemia (ET) or post-polycythemia vera (PV) myelofibrosis
• Treatment-related toxicities from prior therapy resolved to Grade 1 or pre-treatment baseline or determined to be irreversible prior to study treatment
• Must agree to follow specific methods of contraception, if applicable

You may not qualify if:

• Women who are pregnant or breastfeeding at screening
• Any significant acute or uncontrolled chronic medical illness

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (53)

Local Institution - 0069

Newport Beach, California, 92663, United States

Location

Local Institution - 0090

Lake Mary, Florida, 32746, United States

Location

Local Institution - 0043

New Orleans, Louisiana, 70112, United States

Location

Local Institution - 0038

Worcester, Massachusetts, 01655, United States

Location

Local Institution - 0033

Ann Arbor, Michigan, 48109, United States

Location

Local Institution - 0045

Hackensack, New Jersey, 07601, United States

Location

Local Institution - 0076

Chapel Hill, North Carolina, 27514, United States

Location

Local Institution - 0042

Pittsburgh, Pennsylvania, 15224, United States

Location

Local Institution - 0036

Blacktown, New South Wales, 2148, Australia

Location

Local Institution - 0032

Wollongong, New South Wales, 2500, Australia

Location

Local Institution - 0007

East Melbourne, Victoria, 3002, Australia

Location

Local Institution - 0006

Heidelberg, Victoria, 3084, Australia

Location

Local Institution - 0041

Nedlands, Western Australia, 6009, Australia

Location

Local Institution - 0015

West Perth, Western Australia, 6005, Australia

Location

Local Institution - 0030

Brest, 29200, France

Location

Local Institution - 0008

Marseille, 13273, France

Location

Local Institution - 0027

Nice, 06202, France

Location

Local Institution - 0011

Paris, 75010, France

Location

Local Institution - 0010

Villejuif, 94800, France

Location

Local Institution - 0068

Erding, Bavaria, 85435, Germany

Location

Local Institution - 0039

Essen, North Rhine-Westphalia, 45122, Germany

Location

Local Institution - 0040

Chemnitz, Saxony, 09116, Germany

Location

Local Institution - 0035

Halle, Saxony-Anhalt, 06120, Germany

Location

Local Institution - 0050

Lübeck, Schleswig-Holstein, 23538, Germany

Location

Local Institution - 0061

Chaïdári, Attikí, 12462, Greece

Location

Local Institution - 0047

Thessaloniki, Thessaloníki, 570 10, Greece

Location

Local Institution - 0073

Szeged, Csongrád megye, 6725, Hungary

Location

Local Institution - 0072

Nyíregyháza, Szabolcs-Szatmár-Bereg, 4400, Hungary

Location

Local Institution - 0075

Budapest, 1088, Hungary

Location

Local Institution - 0074

Debrecen, 4032, Hungary

Location

Local Institution - 0086

Beersheba, Southern District, 8410101, Israel

Location

Local Institution - 0016

Jerusalem, 9112001, Israel

Location

Local Institution - 0018

Petah Tikva, 4910021, Israel

Location

Local Institution - 0017

Ramat Gan, 5262100, Israel

Location

Local Institution - 0019

Tel Aviv, 6423906, Israel

Location

Local Institution - 0003

Bologna, 40138, Italy

Location

Local Institution - 0002

Brescia, 25123, Italy

Location

Local Institution - 0001

Florence, 50134, Italy

Location

Local Institution - 0012

Verona, 37134, Italy

Location

Local Institution - 0077

Słupsk, Pomeranian Voivodeship, 76-200, Poland

Location

Local Institution - 0062

Gdansk, 80-952, Poland

Location

Local Institution - 0052

Bucuresti, Cluj, 022328, Romania

Location

Local Institution - 0083

Bucharest, 050098, Romania

Location

Local Institution - 0051

Cluj-Napoca, 400015, Romania

Location

Local Institution - 0049

Seongnam, Kyǒnggi-do, 13620, South Korea

Location

Local Institution - 0048

Seoul, Seoul-teukbyeolsi [Seoul], 05505, South Korea

Location

Local Institution - 0053

Seoul, Seoul-teukbyeolsi [Seoul], 06591, South Korea

Location

Local Institution - 0020

Badalona, Barcelona [Barcelona], 08916, Spain

Location

Local Institution - 0029

Santander, Cantabria, 39008, Spain

Location

Local Institution - 0054

Madrid, Madrid, Comunidad de, 28034, Spain

Location

Local Institution - 0026

Madrid, 28041, Spain

Location

Local Institution - 0021

Salamanca, 37007, Spain

Location

Local Institution - 0094

Valencia, 46026, Spain

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Primary Myelofibrosis

Interventions

ruxolitinib; fedratinib

Condition Hierarchy (Ancestors)

Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: March 18, 2021
• First Posted: March 25, 2021
• Study Start: March 22, 2021
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: September 10, 2025

Record last verified: 2025-09

Locations

ES (6); IT (4); IL (5); KR (3); FR (5); RO (3); AU (6); HU (4); DE (5); GR (2); US (8); PL (2)