Who is sponsoring NCT02879695?

NCT02879695 is sponsored by National Cancer Institute (NCI).

What drugs are being tested in NCT02879695?

Interventions in NCT02879695: Biospecimen Collection, Blinatumomab, Bone Marrow Aspiration and Biopsy, Ipilimumab, Nivolumab.

What condition does NCT02879695 study?

NCT02879695 studies Recurrent B Acute Lymphoblastic Leukemia, Recurrent Mixed Phenotype Acute Leukemia, Refractory B Acute Lymphoblastic Leukemia, Refractory Mixed Phenotype Acute Leukemia.

Is NCT02879695 still recruiting?

NCT02879695 is currently active, enrolled. Last updated 15 August 2025.

Are results published for NCT02879695?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-08-15 · How we verify

NCT02879695

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Blinatumomab and Nivolumab With or Without Ipilimumab in Treating Patients With Poor-Risk Relapsed or Refractory CD19+ Precursor B-Lymphoblastic Leukemia

Active, enrolled Phase 1 Results posted Last updated 15 August 2025

What this trial tests

Phase 1 trial testing Biospecimen Collection in Recurrent B Acute Lymphoblastic Leukemia in 28 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

25 October 2017

Primary endpoint
22 May 2023

18 July 2026

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Phase	Phase 1
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	28
Start date	25 October 2017
Primary completion	22 May 2023
Estimated completion	18 July 2026
Sites	7 locations across United States

Drugs / interventions tested

Biospecimen Collection — full drug profile →
Blinatumomab (blinatumomab) — full drug profile →
Bone Marrow Aspiration and Biopsy
Ipilimumab — full drug profile →
Nivolumab (nivolumab) — full drug profile →

Conditions studied

Recurrent B Acute Lymphoblastic Leukemia — all drugs for Recurrent B Acute Lymphoblastic Leukemia →
Recurrent Mixed Phenotype Acute Leukemia — all drugs for Recurrent Mixed Phenotype Acute Leukemia →
Refractory B Acute Lymphoblastic Leukemia — all drugs for Refractory B Acute Lymphoblastic Leukemia →
Refractory Mixed Phenotype Acute Leukemia — all drugs for Refractory Mixed Phenotype Acute Leukemia →

Sponsor

National Cancer Institute (NCI)

Who can join

16 and older, any sex, with Recurrent B Acute Lymphoblastic Leukemia or Recurrent Mixed Phenotype Acute Leukemia. 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.

Number of Participants Experiencing Grade 3, 4, or 5 Adverse Events Primary · Up to 5.5 years

Defined by Common Terminology Criteria for Adverse Events, version 5.0. The highest grade experienced by the participant will be reported.

Group	Value	95% CI
Dose Level A1	0
Dose Level B1	1
Dose Level B-1	1
Dose Expansion (Dose Level A1)	0
Dose Level A1	7
Dose Level B1	2
Dose Level B-1	7
Dose Expansion (Dose Level A1)	3
Dose Level A1	1
Dose Level B1	0
Dose Level B-1	2
Dose Expansion (Dose Level A1)	2
Dose Level A1	0
Dose Level B1	0
Dose Level B-1	1
Dose Expansion (Dose Level A1)	1

Number of Participants With Dose Limiting Toxicities Primary · Up to 5.5 years

Maximum tolerated dose was determined by the absence of dose limiting toxicity in each patient assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Dose Limiting Toxicities were evaluated during treatment; therefore, the time frame is from the first participant starting treatment to the last participant completing treatment.

Group	Value	95% CI
Dose Level A1	1
Dose Level B1	2
Dose Level B-1	1
Dose Expansion (Dose Level A1)	0
Dose Level A1	5
Dose Level B1	1
Dose Level B-1	7
Dose Expansion (Dose Level A1)	6

Count of Participants Responders With Minimal Residual Disease Secondary · Up to 5.5 years

Will be assessed by flow cytometry. Participants who have a clinical response (responders) were evaluated for minimal residual disease negative versus minimal residual disease positive. These are the participants with remission as provided in the Secondary Outcome #4.

Group	Value	95% CI
Dose Level A1	4
Dose Level B1	3
Dose Level B-1	4
Dose Expansion (Dose Level A1)	4
Dose Level A1	1
Dose Level B1	0
Dose Level B-1	1
Dose Expansion (Dose Level A1)	0

Number of Participants Achieving Remission Secondary · Up to 5.5 years

Remission includes participants achieving complete remission or complete remission with incomplete blood count recovery by standard leukemia outcome measures.

Group	Value	95% CI
Dose Level A1	5
Dose Level B1	3
Dose Level B-1	5
Dose Expansion (Dose Level A1)	4
Dose Level A1	3
Dose Level B1	0
Dose Level B-1	6
Dose Expansion (Dose Level A1)	2

Duration of Response Secondary · Up to 5.5 years

Will be analyzed using the Kaplan Meier method. A sensitivity analysis may be performed to evaluate duration of response while excluding patients who go on to have an allogeneic-hematopoietic stem cell transplantation. Time from measured response to progressive disease, death, or study end, assessed up to 2 years after treatment

Group	Value	95% CI
Dose Level A1	205	116 – 844
Dose Level B1	51	44 – 828
Dose Level B-1	695	54 – 849
Dose Expansion (Dose Level A1)	490	155 – 996

Overall Survival Secondary · Up to 5.5 years

Determined from the first day of treatment on the study until death or last known follow up, assessed up to 2 years after completing treatment.

Group	Value	95% CI
Dose Level A1	462	92 – 876
Dose Level B1	182	86 – 864
Dose Level B-1	552	22 – 910
Dose Expansion (Dose Level A1)	381	85 – 857

Adverse events — posted to ClinicalTrials.gov

Time frame: Approximately 6.5 years.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Dose Level A1

Serious: 5/8 (63%)

Deaths: 5/8

Dose Level B1

Serious: 2/3 (67%)

Deaths: 2/3

Dose Level B-1

Serious: 7/11 (64%)

Deaths: 5/11

Dose Expansion (Dose Level A1)

Serious: 2/6 (33%)

Deaths: 2/6

Serious adverse events (34 terms)

Reaction	System	Dose Level A1	Dose Level B1	Dose Level B-1	Dose Expansion (Dose Level…
Alanine Aminotransferase Increased	Investigations	—	—	—	—
Aspartate Aminotransferase Increased	Investigations	—	—	—	—
Dyspnea	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Disseminated Intravascular Coagulation	Blood and lymphatic system disorders	—	—	—	—
Febrile Neutropenia	Blood and lymphatic system disorders	—	—	—	—
Diarrhea	Gastrointestinal disorders	—	—	—	—
Mucositis Oral	Gastrointestinal disorders	—	—	—	—
Disease Progression	General disorders	—	—	—	—
Infusion Related Reaction	General disorders	—	—	—	—
Non Cardiac Chest Pain	General disorders	—	—	—	—
Pain	General disorders	—	—	—	—
GVHD	Immune system disorders	—	—	—	—
Upper Respiratory Infection	Infections and infestations	—	—	—	—
Blood Bilirubin Increased	Investigations	—	—	—	—
Platelet Count Decreased	Investigations	—	—	—	—
Generalized Muscle Weakness	Musculoskeletal and connective tissue disorders	—	—	—	—
Ataxia	Nervous system disorders	—	—	—	—
Cerebellar Syndrome	Nervous system disorders	—	—	—	—
Dysphasia	Nervous system disorders	—	—	—	—
Seizure	Nervous system disorders	—	—	—	—
Syncope	Nervous system disorders	—	—	—	—
Transient Ischemic Attacks	Nervous system disorders	—	—	—	—
Confusion	Psychiatric disorders	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Hypoxia	Respiratory, thoracic and mediastinal disorders	—	—	—	—

Other adverse events (192 terms — click to expand)

Reaction	System	Dose Level A1	Dose Level B1	Dose Level B-1	Dose Expansion (Dose Level…
Lymphocyte Count Decreased	Investigations	—	—	—	—
Platelet Count Decreased	Investigations	—	—	—	—
White Blood Cell Decreased	Investigations	—	—	—	—
Febrile Neutropenia	Blood and lymphatic system disorders	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—
Alanine Aminotransferase Increased	Investigations	—	—	—	—
Aspartate Aminotransferase Increased	Investigations	—	—	—	—
Blood Bilirubin Increased	Investigations	—	—	—	—
INR Increased	Investigations	—	—	—	—
Hyperglycemia	Metabolism and nutrition disorders	—	—	—	—
Headache	Nervous system disorders	—	—	—	—
Anemia	Blood and lymphatic system disorders	—	—	—	—
Sinus Tachycardia	Cardiac disorders	—	—	—	—
Fatigue	General disorders	—	—	—	—
Fever	General disorders	—	—	—	—
Neutrophil Count Decreased	Investigations	—	—	—	—
Hypoalbuminemia	Metabolism and nutrition disorders	—	—	—	—
Hypophosphatemia	Metabolism and nutrition disorders	—	—	—	—
Hypertension	Vascular disorders	—	—	—	—
Pain	General disorders	—	—	—	—
Cytokine Release Syndrome	Immune system disorders	—	—	—	—
Alkaline Phosphatase Increased	Investigations	—	—	—	—
Anorexia	Metabolism and nutrition disorders	—	—	—	—
Hypocalcemia	Metabolism and nutrition disorders	—	—	—	—
Hypokalemia	Metabolism and nutrition disorders	—	—	—	—
Tremor	Nervous system disorders	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Dyspnea	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Rash Maculo-papular	Skin and subcutaneous tissue disorders	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—
Diarrhea	Gastrointestinal disorders	—	—	—	—
Mucositis Oral	Gastrointestinal disorders	—	—	—	—
Chills	General disorders	—	—	—	—
Edema Limbs	General disorders	—	—	—	—
Non-cardiac Chest Pain	General disorders	—	—	—	—
Activated Partial Thromboplastin Time Prolonged	Investigations	—	—	—	—
Lipase Increased	Investigations	—	—	—	—
Hyponatremia	Metabolism and nutrition disorders	—	—	—	—
Hypotension	Vascular disorders	—	—	—	—
Disseminated Intravascular Coagulation	Blood and lymphatic system disorders	—	—	—	—

Most-reported serious reactions: Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Dyspnea, Disseminated Intravascular Coagulation, Febrile Neutropenia, Diarrhea, Mucositis Oral, Disease Progression.

Data from ClinicalTrials.gov NCT02879695 adverse events section.

Sponsor's own description

This phase I trial studies the side effects and best dose of blinatumomab when given with nivolumab alone or nivolumab and ipilimumab in treating patients with poor-risk CD19+ precursor B-lymphoblastic leukemia that has come back after a period of improvement (relapsed) or has not responded to treatment (refractory). Immunotherapy with monoclonal antibodies, such as blinatumomab, nivolumab, and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Publications & conference data

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

The landscape of bispecific T cell engager in cancer treatment.
Zhou S, Liu M, Ren F, Meng X, et al · · 2021 · cited 172× · PMID 34039409 · DOI 10.1186/s40364-021-00294-9
Redirecting T cells to hematological malignancies with bispecific antibodies.
Velasquez MP, Bonifant CL, Gottschalk S. · · 2018 · cited 134× · PMID 29118005 · DOI 10.1182/blood-2017-06-741058
Evolving therapy of adult acute lymphoblastic leukemia: state-of-the-art treatment and future directions.
Samra B, Jabbour E, Ravandi F, Kantarjian H, et al · · 2020 · cited 110× · PMID 32503572 · DOI 10.1186/s13045-020-00905-2
Recent developments in immunotherapy of acute myeloid leukemia.
Lichtenegger FS, Krupka C, Haubner S, Köhnke T, et al · · 2017 · cited 103× · PMID 28743264 · DOI 10.1186/s13045-017-0505-0
Rationale for Combining Bispecific T Cell Activating Antibodies With Checkpoint Blockade for Cancer Therapy.
Kobold S, Pantelyushin S, Rataj F, Vom Berg J. · · 2018 · cited 83× · PMID 30090763 · DOI 10.3389/fonc.2018.00285
Overcoming the challenges associated with CD3+ T-cell redirection in cancer.
Singh A, Dees S, Grewal IS. · · 2021 · cited 82× · PMID 33469153 · DOI 10.1038/s41416-020-01225-5
Limitations and opportunities for immune checkpoint inhibitors in pediatric malignancies.
Park JA, Cheung NV. · · 2017 · cited 81× · PMID 28622628 · DOI 10.1016/j.ctrv.2017.05.006
Bispecific, T-Cell-Recruiting Antibodies in B-Cell Malignancies.
Lejeune M, Köse MC, Duray E, Einsele H, et al · · 2020 · cited 70× · PMID 32457743 · DOI 10.3389/fimmu.2020.00762

Verify or expand the search:

Other trials of Biospecimen Collection

Trials testing the same drug.

NCT07229339 — Zipalertinib With Carboplatin and Pemetrexed for the Treatment of Resectable, Stage II-IIIB, Non-Small Cell Lung Cancer · Phase 2 · not yet recruiting
NCT07441681 — Comparing Radiation Plus Cetuximab to Radiation Plus Chemotherapy in People With Head and Neck Cancer Who Cannot Receive · Phase 3 · not yet recruiting
NCT07365306 — Epcoritamab, Rituximab, Gemcitabine and Oxaliplatin (R-GemOx) as Salvage Therapy Before Autologous Stem Cell Transplant · Phase 2 · not yet recruiting
NCT07147231 — Testing the Effectiveness of the Anti-cancer Drug Pidnarulex (CX-5461), in Combination With Another Anti-cancer Drug Cem · Phase 1, PHASE2 · recruiting
NCT07572123 — Evaluating the Addition of Maintenance Immunotherapy Compared to the Usual Treatment of Chemotherapy and Autologous Stem · Phase 2, PHASE3 · not yet recruiting

Other recruiting trials for Recurrent B Acute Lymphoblastic Leukemia

Currently open trials in the same condition.

NCT07133997 — Recombinant Erwinia Asparaginase and Venetoclax in Combination With Blinatumomab for the Treatment of Relapsed or Refrac · Phase 1 · recruiting
NCT04872790 — Venetoclax, Dasatinib, Prednisone, Rituximab and Blinatumomab for the Treatment of Newly Diagnosed or Relapsed Philadelp · Phase 1 · recruiting
NCT05418088 — Genetically Engineered Cells (Anti-CD19/CD20/CD22 CAR T-cells) for the Treatment of Relapsed or Refractory Lymphoid Mali · Phase 1 · recruiting
NCT04546399 — A Study to Compare Blinatumomab Alone to Blinatumomab With Nivolumab in Patients Diagnosed With First Relapse B-Cell Acu · Phase 2 · recruiting
NCT03739814 — Inotuzumab Ozogamicin and Blinatumomab With or Without Ponatinib in Treating Patients With Newly Diagnosed, Recurrent, o · Phase 2 · recruiting

Other National Cancer Institute (NCI) trials

Trials by the same sponsor.

NCT07147231 — Testing the Effectiveness of the Anti-cancer Drug Pidnarulex (CX-5461), in Combination With Another Anti-cancer Drug Cem · Phase 1, PHASE2 · recruiting
NCT07572123 — Evaluating the Addition of Maintenance Immunotherapy Compared to the Usual Treatment of Chemotherapy and Autologous Stem · Phase 2, PHASE3 · not yet recruiting
NCT07281417 — Testing the Addition of Cemiplimab (REGN2810) to Chemotherapy Treatment Given Prior to Surgery in Patients With Sinonasa · Phase 2 · recruiting
NCT07012044 — A Study to Find the Highest Dose of Cedazuridine and Decitabine Combination With Filgrastim as a Treatment Option After · Phase 1 · not yet recruiting
NCT07437950 — Comparing Different Treatment Lengths for Venetoclax in Older People With Newly Diagnosed Acute Myeloid Leukemia (A Myel · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02879695 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Cancer Institute (NCI)
Last refreshed: 15 August 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02879695.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing