NCT03927105

Nivolumab and the Antagonistic CSF-1R Monoclonal Antibody Cabiralizumab (BMS-986227) in Patients With Relapsed/Refractory Peripheral T Cell Lymphoma

Completed Phase 2 Results posted Last updated 18 March 2024

What this trial tests

Phase 2 trial testing Nivolumab in Peripheral T Cell Lymphoma in 4 participants. Completed in 6 July 2023.

Timeline

25 April 2019

Primary endpoint
1 November 2019

6 July 2023

Quick facts

Lead sponsor	University of Michigan Rogel Cancer Center
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	4
Start date	25 April 2019
Primary completion	1 November 2019
Estimated completion	6 July 2023
Sites	3 locations across United States

Drugs / interventions tested

• Nivolumab (nivolumab) — full drug profile →
• cabiralizumab — full drug profile →

Conditions studied

• Peripheral T Cell Lymphoma — all drugs for Peripheral T Cell Lymphoma →

Sponsor

University of Michigan Rogel Cancer Center

Who can join

18 and older, any sex, with Peripheral T Cell Lymphoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Overall Response Rate (ORR) at Four Months (LYRIC Criteria) Primary · 4 months

Overall Response Rate (CR + PR) as determined by LYRIC (LYmphoma Response to Immunomodulatory therapy Criteria), at four months (shown as number of participants with CR or PR at 4 months). LYRIC: An adaptation of the Lugano classification developed because discriminating true progressive disease from pseudoprogression in lymphoma patients receiving immunomodulatory agents is challenging. To address this challenge, the LYRIC criteria incorporated the response category of "indeterminate response" (IR). * IR(1): ≥ 50% increase in overall tumor burden (sum of the product of the perpendicular dia

Group	Value	95% CI
Nivolumab + Cabiralizumab	2
Nivolumab + Cabiralizumab	0
Nivolumab + Cabiralizumab	1

Complete Response Rate (CRR) at Four Months Primary · 4 months

Complete response rate, as determined by LYRIC criteria, at four months (reported as number of participants with CR at 4 months). LYRIC: An adaptation of the Lugano classification developed because discriminating true progressive disease from pseudoprogression in lymphoma patients receiving immunomodulatory agents is challenging. To address this challenge, the LYRIC criteria incorporated the response category of "indeterminate response" (IR). * IR(1): ≥ 50% increase in overall tumor burden (sum of the product of the perpendicular diameters (SPD) of up to 6 target measurable nodes and extrano

Group	Value	95% CI
Nivolumab + Cabiralizumab	2

Overall Response at Four Months by (LUGANO 2014) Criteria Secondary · four months

Overall response (CR + PR), as determined by LUGANO 2014 criteria (reported as number of participants with a CR or PR at 4 months). The Lugano classification is utilized for both lymphoma staging and response assessment and incorporates PET-CT imaging. Responses are described as either partial or complete, with a complete response requiring disappearance of metabolically active sites of disease.

Group	Value	95% CI
Nivolumab + Cabiralizumab	2
Nivolumab + Cabiralizumab	0
Nivolumab + Cabiralizumab	1

Complete Response Rate at Four Months (LUGANO 2014) Criteria Secondary · four months

Complete Response Rate, as determined by LUGANO 2014 criteria, at (reported as number of participants with a CR at 4 months). The Lugano classification is utilized for both lymphoma staging and response assessment and incorporates PET-CT imaging. A complete response requires disappearance of metabolically active sites of disease.

Group	Value	95% CI
Nivolumab + Cabiralizumab	2

Adverse events — posted to ClinicalTrials.gov

Time frame: From time of consent through 100 days post treatment discontinuation. Longest actual collection for AEs: 13 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Nivolumab + Cabiralizumab

Serious: 2/3 (67%)

Deaths: 1/3

Serious adverse events (3 terms)

Reaction	System	Nivolumab + Cabiralizumab
ADRENAL INSUFFICIENCY	Endocrine disorders	—
ENDOCARDITIS INFECTIVE	Infections and infestations	—
SEPSIS	Infections and infestations	—

Other adverse events (21 terms — click to expand)

Reaction	System	Nivolumab + Cabiralizumab
PERIORBITAL EDEMA	Eye disorders	—
FATIGUE	General disorders	—
ANOREXIA	Metabolism and nutrition disorders	—
ABDOMINAL PAIN	Gastrointestinal disorders	—
DIARRHEA	Gastrointestinal disorders	—
MUCOSITIS ORAL	Gastrointestinal disorders	—
NAUSEA	Gastrointestinal disorders	—
VOMITING	Gastrointestinal disorders	—
CHILLS	General disorders	—
FEVER	General disorders	—
NON-CARDIAC CHEST PAIN	General disorders	—
INFECTIONS AND INFESTATIONS - OTHER, SPECIFY	Infections and infestations	—
UPPER RESPIRATORY INFECTION	Infections and infestations	—
WEIGHT LOSS	Investigations	—
NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) - OTHER, SPECIFY	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
HEADACHE	Nervous system disorders	—
INSOMNIA	Psychiatric disorders	—
COUGH	Respiratory, thoracic and mediastinal disorders	—
NASAL CONGESTION	Respiratory, thoracic and mediastinal disorders	—
SORE THROAT	Respiratory, thoracic and mediastinal disorders	—
PRURITUS	Skin and subcutaneous tissue disorders	—

Most-reported serious reactions: ADRENAL INSUFFICIENCY, ENDOCARDITIS INFECTIVE, SEPSIS.

Data from ClinicalTrials.gov NCT03927105 adverse events section.

Sponsor's own description

A multicenter trial evaluating the combination of nivolumab and the antagonistic CSF-1R monoclonal antibody cabiralizumab (BMS-986227) in patients with relapsed/refractory peripheral T cell lymphoma

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Macrophages in immunoregulation and therapeutics.
   Chen S, Saeed AFUH, Liu Q, Jiang Q, et al · · 2023 · cited 1250× · PMID 37211559 · DOI 10.1038/s41392-023-01452-1
2. Targeting macrophages in cancer immunotherapy.
   Duan Z, Luo Y. · · 2021 · cited 462× · PMID 33767177 · DOI 10.1038/s41392-021-00506-6
3. Immunosuppressive cells in cancer: mechanisms and potential therapeutic targets.
   Tie Y, Tang F, Wei YQ, Wei XW. · · 2022 · cited 386× · PMID 35585567 · DOI 10.1186/s13045-022-01282-8
4. The Evasion Mechanisms of Cancer Immunity and Drug Intervention in the Tumor Microenvironment.
   Kim SK, Cho SW. · · 2022 · cited 300× · PMID 35685630 · DOI 10.3389/fphar.2022.868695
5. Tumor-associated macrophages: potential therapeutic strategies and future prospects in cancer.
   Li C, Xu X, Wei S, Jiang P, et al · · 2021 · cited 259× · PMID 33504575 · DOI 10.1136/jitc-2020-001341
6. Tissue macrophages: origin, heterogenity, biological functions, diseases and therapeutic targets.
   Guan F, Wang R, Yi Z, Luo P, et al · · 2025 · cited 155× · PMID 40055311 · DOI 10.1038/s41392-025-02124-y
7. Immuno-Metabolism and Microenvironment in Cancer: Key Players for Immunotherapy.
   Giannone G, Ghisoni E, Genta S, Scotto G, et al · · 2020 · cited 119× · PMID 32575899 · DOI 10.3390/ijms21124414
8. Defects in Macrophage Reprogramming in Cancer Therapy: The Negative Impact of PD-L1/PD-1.
   Cai H, Zhang Y, Wang J, Gu J. · · 2021 · cited 100× · PMID 34248982 · DOI 10.3389/fimmu.2021.690869