NCT02587962 is a Phase 1, PHASE2 clinical trial of Birinapant in Solid Tumors, sponsored by Medivir.

Who is sponsoring NCT02587962?

NCT02587962 is sponsored by Medivir.

What drugs are being tested in NCT02587962?

Interventions in NCT02587962: Birinapant, Pembrolizumab.

What condition does NCT02587962 study?

NCT02587962 studies Solid Tumors.

Is NCT02587962 still recruiting?

NCT02587962 is currently terminated. Last updated 14 January 2021.

Are results published for NCT02587962?

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

Last reviewed 2021-01-14 · How we verify

NCT02587962

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

Dose-escalation Study of Birinapant and Pembrolizumab in Solid Tumors

Terminated Phase 1, PHASE2 Results posted Last updated 14 January 2021

What this trial tests

Phase 1, PHASE2 trial testing Birinapant in Solid Tumors in 34 participants. Terminated before completion.

Timeline

4 August 2017

Primary endpoint
17 February 2020

17 February 2020

Quick facts

Lead sponsor	Medivir
Phase	Phase 1, PHASE2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	34
Start date	4 August 2017
Primary completion	17 February 2020
Estimated completion	17 February 2020
Sites	9 locations across United States

Drugs / interventions tested

Birinapant — full drug profile →
Pembrolizumab (pembrolizumab) — full drug profile →

Conditions studied

Solid Tumors — all drugs for Solid Tumors →

Sponsor

Medivir — full company profile →

Who can join

18 and older, any sex, with Solid Tumors. 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.

Blood Pressure (Safety and Tolerability in the Dose Escalation Phase) Primary · Baseline and up to 2 yrs (follow-up)

Evaluation of the safety and tolerability of birinapant when given in combination with pembrolizumab assessed through blood pressure.

Systolic blood pressure at baseline

Group	Value	95% CI
Phase 1 - 5.6 mg	137.3	± 18.6
Phase 1 - 11 mg	143.3	± 14.5
Phase 1 - 17 mg	134.0	± 22.1
Phase 1 - 22 mg	118.6	± 11.4

Systolic blood pressure at follow-up

Group	Value	95% CI
Phase 1 - 5.6 mg	120.0	± NA
Phase 1 - 11 mg	107.0	± 1.4
Phase 1 - 17 mg	119.7	± 30.2
Phase 1 - 22 mg	120.0	± NA

Diastolic blood pressure at baseline

Group	Value	95% CI
Phase 1 - 5.6 mg	78.0	± 2.0
Phase 1 - 11 mg	77.0	± 15.5
Phase 1 - 17 mg	74.3	± 9.3
Phase 1 - 22 mg	66.6	± 7.9

Diastolic blood pressure at follow-up

Group	Value	95% CI
Phase 1 - 5.6 mg	84.0	± NA
Phase 1 - 11 mg	66.0	± 8.5
Phase 1 - 17 mg	71.3	± 11.4
Phase 1 - 22 mg	75.0	± NA

Electrocardiogram: QT Interval (Safety and Tolerability in the Dose Escalation Phase) Primary · Baseline and up to 2 yrs (follow-up)

Evaluation of the safety and tolerability of birinapant when given in combination with pembrolizumab assessed through electrocardiogram.

Electrocardiogram QT interval at baseline

Group	Value	95% CI
Phase 1 - 5.6 mg	368.7	± 30.6
Phase 1 - 11 mg	388.3	± 11.2
Phase 1 - 17 mg	386.3	± 32.9
Phase 1 - 22 mg	365.9	± 32.7

Electrocardiogram QT interval at follow-up

Group	Value	95% CI
Phase 1 - 5.6 mg	392.0	± NA
Phase 1 - 17 mg	380.0	± NA
Phase 1 - 22 mg	364.0	± NA

Amylase and Lipase (Safety and Tolerability in the Dose Escalation Phase) Primary · Baseline and up to 2 yrs (follow-up)

Evaluation of the safety and tolerability of birinapant when given in combination with pembrolizumab assessed through amylase and lipase.

Amylase at baseline

Group	Value	95% CI
Phase 1 - 5.6 mg	33.7	± 32.5
Phase 1 - 11 mg	38.3	± 9.0
Phase 1 - 17 mg	64.3	± 8.0
Phase 1 - 22 mg	40.6	± 27.4

Amylase at follow-up

Group	Value	95% CI
Phase 1 - 5.6 mg	27.0	± NA
Phase 1 - 11 mg	49.0	± 41.0
Phase 1 - 17 mg	56.5	± 38.9
Phase 1 - 22 mg	60.0	± NA

Lipase at baseline

Group	Value	95% CI
Phase 1 - 5.6 mg	17.0	± 12.2
Phase 1 - 11 mg	24.0	± 21.0
Phase 1 - 17 mg	32.2	± 21.4
Phase 1 - 22 mg	49.9	± 63.3

Lipase at follow-up

Group	Value	95% CI
Phase 1 - 5.6 mg	12.0	± NA
Phase 1 - 11 mg	15.5	± 10.6
Phase 1 - 17 mg	16.0	± 2.8
Phase 1 - 22 mg	18.0	± NA

Thyroxine Free (Safety and Tolerability in the Dose Escalation Phase) Primary · Baseline and up to 2 yrs (follow-up)

Evaluation of the safety and tolerability of birinapant when given in combination with pembrolizumab assessed through thyroxine free.

Thyroxine free at baseline

Group	Value	95% CI
Phase 1 - 5.6 mg	16.8	± 5.0
Phase 1 - 11 mg	15.0	± 3.0
Phase 1 - 17 mg	15.0	± 3.3
Phase 1 - 22 mg	18.7	± 1.6

Thyroxine free at last assessment

Group	Value	95% CI
Phase 1 - 5.6 mg	25.2	± 8.0
Phase 1 - 11 mg	16.7	± 5.4
Phase 1 - 17 mg	16.9	± 4.1
Phase 1 - 22 mg	16.5	± 3.6

Thyrotropin (Safety and Tolerability in the Dose Escalation Phase) Primary · Baseline and up to 2 yrs (follow-up)

Evaluation of the safety and tolerability of birinapant when given in combination with pembrolizumab assessed through Thyrotropin.

Thyrotropin at baseline

Group	Value	95% CI
Phase 1 - 5.6 mg	3.8	± 3.2
Phase 1 - 11 mg	2.4	± 0.9
Phase 1 - 17 mg	1.7	± 0.8
Phase 1 - 22 mg	1.4	± 0.9

Thyrotropin at last assessment

Group	Value	95% CI
Phase 1 - 5.6 mg	14.2	± 18.7
Phase 1 - 11 mg	7.7	± 4.0
Phase 1 - 17 mg	2.3	± 1.3
Phase 1 - 22 mg	2.6	± 2.1

Hemoglobin (Safety and Tolerability in the Dose Escalation Phase) Primary · Baseline and up to 2 yrs (follow-up)

Evaluation of the safety and tolerability of birinapant when given in combination with pembrolizumab assessed through hemoglobin.

Hemoglobin at baseline

Group	Value	95% CI
Phase 1 - 5.6 mg	110.3	± 20.2
Phase 1 - 11 mg	107.3	± 8.6
Phase 1 - 17 mg	112.0	± 11.8
Phase 1 - 22 mg	102.0	± 16.0

Hemoglobin at follow-up

Group	Value	95% CI
Phase 1 - 5.6 mg	89.0	± NA
Phase 1 - 11 mg	107.0	± 14.1
Phase 1 - 17 mg	116.0	± 19.8
Phase 1 - 22 mg	99.0	± NA

Physical Exam (Safety and Tolerability in the Dose Escalation Phase) Primary · Baseline and up to 2 yrs (follow-up)

Evaluation of the safety and tolerability of birinapant when given in combination with pembrolizumab assessed through physical exam.

Clinically significant physical exam abnormalities - baseline

Group	Value	95% CI
Phase 1 - 5.6 mg	0
Phase 1 - 11 mg	0
Phase 1 - 17 mg	3
Phase 1 - 22 mg	0

Clinically significant physical exam abnormalities - last assessment

Group	Value	95% CI
Phase 1 - 5.6 mg	0
Phase 1 - 11 mg	1
Phase 1 - 17 mg	3
Phase 1 - 22 mg	0

Overall Response (Applicable for: Dose Escalation Phase and Dose Expansion Phase in Cohorts of Colorectal Cancer, Ovarian Cancer and Cervical Cancer) Primary · Baseline and up to 2 yrs (follow-up)

Evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. A responder was a patient who showed best overall response of complete response (CR, disappearance of all target lesions) or partial response (PR, ≥30% decrease in the sum of the longest diameter of target lesions), which was confirmed again at least 4 weeks after the initial assessment.

Group	Value	95% CI
Phase 1 - 5.6 mg	1
Phase 1 - 11 mg	0
Phase 1 - 17 mg	0
Phase 1 - 22 mg	0
Phase 2 CRC - 22 mg	0

Tumor Response Evaluated Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1: Secondary · Every 9 weeks; up to 2 yrs

Analysis of progression-free survival (PFS); time to progression, where progressive disease (PD) corresponds to ≥20% increase in the sum of the longest diameter of target lesions.

Group	Value	95% CI
Phase 1 - 5.6 mg	15.4	11.3 – NA
Phase 1 - 11 mg	7.7	4.0 – 9.6
Phase 1 - 17 mg	8.6	8.0 – 26.0
Phase 1 - 22 mg	8.0	4.1 – 8.9
Phase 2 CRC - 22 mg	9.0	8.1 – 18.1

Blood Pressure (Safety and Tolerability in the Dose Expansion Phase - Colorectal Cancer Cohort) Secondary · Baseline and up to 2 yrs (follow-up)

Evaluation of the safety and tolerability of birinapant at the recommended phase 2 dose (RP2D) when given in combination with pembrolizumab assessed through blood pressure.

Systolic blood pressure at baseline

Group	Value	95% CI
Phase 2 CRC - 22 mg	130.9	± 20.3

Systolic blood pressure at follow-up

Group	Value	95% CI
Phase 2 CRC - 22 mg	129.3	± 16.6

Diastolic blood pressure at baseline

Group	Value	95% CI
Phase 2 CRC - 22 mg	80.0	± 8.0

Diastolic blood pressure at follow-up

Group	Value	95% CI
Phase 2 CRC - 22 mg	74.4	± 12.2

Electrocardiogram: QT Interval (Safety and Tolerability in the Dose Expansion Phase - Colorectal Cancer Cohort) Secondary · Baseline and up to 2 yrs (follow-up)

Evaluation of the safety and tolerability of birinapant at the recommended phase 2 dose (RP2D) when given in combination with pembrolizumab assessed through electrocardiogram.

Electrocardiogram QT interval at baseline

Group	Value	95% CI
Phase 2 CRC - 22 mg	383.5	± 25.6

Electrocardiogram QT interval at follow-up

Group	Value	95% CI
Phase 2 CRC - 22 mg	392.6	± 38.7

Amylase and Lipase (Safety and Tolerability in the Dose Expansion Phase - Colorectal Cancer Cohort) Secondary · Baseline and up to 2 yrs (follow-up)

Evaluation of the safety and tolerability of birinapant at the recommended phase 2 dose (RP2D) when given in combination with pembrolizumab assessed through amylase and lipase.

Amylase at baseline

Group	Value	95% CI
Phase 2 CRC - 22 mg	68.9	± 22.5

Amylase at follow-up

Group	Value	95% CI
Phase 2 CRC - 22 mg	93.0	± 35.4

Lipase at baseline

Group	Value	95% CI
Phase 2 CRC - 22 mg	44.3	± 41.1

Lipase at follow-up

Group	Value	95% CI
Phase 2 CRC - 22 mg	29.7	± 16.6

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 2 years. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Phase 1 - 5.6 mg

Serious: 2/3 (67%)

Deaths: 0/3

Phase 1 - 11 mg

Serious: 1/3 (33%)

Deaths: 0/3

Phase 1 - 17 mg

Serious: 4/6 (67%)

Deaths: 1/6

Phase 1 - 22 mg

Serious: 3/7 (43%)

Deaths: 0/7

Phase 2 CRC - 22 mg

Serious: 5/15 (33%)

Deaths: 1/15

Serious adverse events (31 terms)

Reaction	System	Phase 1 - 5.6 mg	Phase 1 - 11 mg	Phase 1 - 17 mg	Phase 1 - 22 mg	Phase 2 CRC - 22 mg
Smal intestinal obstruction	Gastrointestinal disorders	—	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—
Transient ischaemic attack	Nervous system disorders	—	—	—	—	—
Acute kidney injury	Renal and urinary disorders	—	—	—	—	—
Mental status changes	Psychiatric disorders	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—
Dysphagia	Gastrointestinal disorders	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—
Stomatitis	Gastrointestinal disorders	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—
Death	General disorders	—	—	—	—	—
Hip fracture	Injury, poisoning and procedural complications	—	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Asthenia	General disorders	—	—	—	—	—
Hyponatraemia	Metabolism and nutrition disorders	—	—	—	—	—
Brain oedema	Nervous system disorders	—	—	—	—	—
Pneumonia staphylococcal	Infections and infestations	—	—	—	—	—
Sepsis	Infections and infestations	—	—	—	—	—
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	—	—	—	—	—
Malignant ascites	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—
Pneumonitis bacterial	Infections and infestations	—	—	—	—	—
Pleural effusion	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Portal hypertension	Hepatobiliary disorders	—	—	—	—	—

Other adverse events (135 terms — click to expand)

Reaction	System	Phase 1 - 5.6 mg	Phase 1 - 11 mg	Phase 1 - 17 mg	Phase 1 - 22 mg	Phase 2 CRC - 22 mg
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Lipase increased	Investigations	—	—	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—
Amylase increased	Investigations	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—
Hyponatraemia	Metabolism and nutrition disorders	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—	—	—
Blood alkaline phosphatase increased	Investigations	—	—	—	—	—
Insomnia	Psychiatric disorders	—	—	—	—	—
Weight increased	Investigations	—	—	—	—	—
Pruritus generalised	Skin and subcutaneous tissue disorders	—	—	—	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—	—	—	—
Blood creatinine increased	Investigations	—	—	—	—	—
Dehydration	Metabolism and nutrition disorders	—	—	—	—	—
Abdominal distension	Gastrointestinal disorders	—	—	—	—	—
Rash maculo-papular	Skin and subcutaneous tissue disorders	—	—	—	—	—
Vulvovaginal mycotic infection	Infections and infestations	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—
Vision blurred	Eye disorders	—	—	—	—	—
Oedema peripheral	General disorders	—	—	—	—	—
Rash pruritic	Skin and subcutaneous tissue disorders	—	—	—	—	—
Hypophosphataemia	Metabolism and nutrition disorders	—	—	—	—	—
Hypotension	Vascular disorders	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—
Confusional state	Psychiatric disorders	—	—	—	—	—
Hypoalbuminaemia	Metabolism and nutrition disorders	—	—	—	—	—
Pneumonitis	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Rash erythematous	Skin and subcutaneous tissue disorders	—	—	—	—	—
Rash papular	Skin and subcutaneous tissue disorders	—	—	—	—	—
Chills	General disorders	—	—	—	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Anxiety	Psychiatric disorders	—	—	—	—	—

Most-reported serious reactions: Smal intestinal obstruction, Dyspnoea, Abdominal pain, Transient ischaemic attack, Acute kidney injury, Mental status changes, Pyrexia, Dysphagia.

Data from ClinicalTrials.gov NCT02587962 adverse events section.

Sponsor's own description

An ascending dose study in patients with solid tumors to evaluate the safety, tolerability, pharmacodynamics and efficacy of birinapant when given in combination with pembrolizumab. A dose expansion phase of 4 cohorts will also be included.

Publications & conference data

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

Targeting apoptosis in cancer therapy.
Carneiro BA, El-Deiry WS. · · 2020 · cited 1823× · PMID 32203277 · DOI 10.1038/s41571-020-0341-y
Apoptosis: A Comprehensive Overview of Signaling Pathways, Morphological Changes, and Physiological Significance and Therapeutic Implications.
Mustafa M, Ahmad R, Tantry IQ, Ahmad W, et al · · 2024 · cited 264× · PMID 39594587 · DOI 10.3390/cells13221838
Recent advances in targeting the "undruggable" proteins: from drug discovery to clinical trials.
Xie X, Yu T, Li X, Zhang N, et al · · 2023 · cited 246× · PMID 37669923 · DOI 10.1038/s41392-023-01589-z
Mitochondria-associated programmed cell death as a therapeutic target for age-related disease.
Nguyen TT, Wei S, Nguyen TH, Jo Y, et al · · 2023 · cited 221× · PMID 37612409 · DOI 10.1038/s12276-023-01046-5
Integrated drug profiling and CRISPR screening identify essential pathways for CAR T-cell cytotoxicity.
Dufva O, Koski J, Maliniemi P, Ianevski A, et al · · 2020 · cited 178× · PMID 31830245 · DOI 10.1182/blood.2019002121
Smac mimetics synergize with immune checkpoint inhibitors to promote tumour immunity against glioblastoma.
Beug ST, Beauregard CE, Healy C, Sanda T, et al · · 2017 · cited 118× · PMID 28198370 · DOI 10.1038/ncomms14278
Future Therapeutic Directions for Smac-Mimetics.
Morrish E, Brumatti G, Silke J. · · 2020 · cited 108× · PMID 32053868 · DOI 10.3390/cells9020406
A Review of the Current Impact of Inhibitors of Apoptosis Proteins and Their Repression in Cancer.
Cetraro P, Plaza-Diaz J, MacKenzie A, Abadía-Molina F. · · 2022 · cited 85× · PMID 35406442 · DOI 10.3390/cancers14071671

Verify or expand the search:

Other trials of Birinapant

Trials testing the same drug.

NCT04553692 — Phase 1a/1b Study of Aplitabart (IGM-8444) Alone or in Combination in Participants with Relapsed, Refractory, or Newly D · Phase 1 · terminated
NCT03803774 — Birinapant and Intensity Modulated Re-Irradiation Therapy in Treating Patients With Locally Recurrent Head and Neck Squa · Phase 1 · active not recruiting
NCT02756130 — Birinapant and Carboplatin in Treating Patients and Targeting Recurrent High Grade Ovarian, Fallopian Tube, or Primary P · Phase 1, PHASE2 · withdrawn

Other recruiting trials for Solid Tumors

Currently open trials in the same condition.

NCT07529002 — Clinical Application of 89Zr-s-C1 PET/CT Imaging in Solid Tumors · recruiting
NCT07416123 — A Study of GEN1106 in Participants With Solid Tumors · Phase 1 · recruiting
NCT07522073 — A Study to Evaluate Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancre · Phase 3 · recruiting
NCT07395258 — A Study to Test Different Doses of BI 3923948 Alone and in Combination With an Anti-PD-1 Antibody in People With Differe · Phase 1 · recruiting
NCT07505069 — Exploring the Clinical Value of RT01-89Zr PET Imaging in Solid Tumors · EARLY_PHASE1 · recruiting

Other Medivir trials

Trials by the same sponsor.

NCT03781934 — A Study to Evaluate MIV-818 in Patients With Liver Cancer Manifestations · Phase 1, PHASE2 · completed
NCT03443453 — A Bioavailability Study of MIV-711 Oral Formulations in Healthy Volunteers · Phase 1 · completed
NCT02705625 — A Study to Evaluate the Efficacy, Safety and Tolerability of MIV-711 in Osteoarthritis Patients · Phase 2 · completed

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 NCT02587962 (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 Medivir
Last refreshed: 14 January 2021

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/NCT02587962.

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