NCT02603419 is a Phase 1 clinical trial of Avelumab in Hodgkins Lymphoma, sponsored by Pfizer.

Who is sponsoring NCT02603419?

NCT02603419 is sponsored by Pfizer.

What drugs are being tested in NCT02603419?

Interventions in NCT02603419: Avelumab, Avelumab, Avelumab, Avelumab, Avelumab, Avelumab.

What condition does NCT02603419 study?

NCT02603419 studies Hodgkins Lymphoma.

Is NCT02603419 still recruiting?

NCT02603419 is currently terminated. Last updated 24 April 2020.

Are results published for NCT02603419?

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

Last reviewed 2020-04-24 · How we verify

NCT02603419

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

Avelumab In Patients With Previously Treated Advanced Stage Classical Hodgkin's Lymphoma (JAVELIN HODGKINS)

Terminated Phase 1 Results posted Last updated 24 April 2020

What this trial tests

Phase 1 trial testing Avelumab in Hodgkins Lymphoma in 34 participants. Terminated before completion.

Timeline

10 March 2016

Primary endpoint
1 December 2018

11 April 2019

Quick facts

Lead sponsor	Pfizer
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	34
Start date	10 March 2016
Primary completion	1 December 2018
Estimated completion	11 April 2019
Sites	13 locations across Italy, United Kingdom, United States

Drugs / interventions tested

Avelumab (avelumab) — full drug profile →
Avelumab (avelumab) — full drug profile →
Avelumab (avelumab) — full drug profile →
Avelumab (avelumab) — full drug profile →
Avelumab (avelumab) — full drug profile →
Avelumab (avelumab) — full drug profile →

Conditions studied

Hodgkins Lymphoma — all drugs for Hodgkins Lymphoma →

Sponsor

Pfizer — full company profile →

Who can join

18 and older, any sex, with Hodgkins 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.

Lead-in Phase: Percent Target Occupancy (CD14+ Monocytes) at Day 2 of Cycle 1 Primary · Day 2 of Cycle 1

Target occupancy on peripheral blood CD14+ T-cells by avelumab was investigated in human blood in vitro by flow cytometry.

Group	Value	95% CI
Lead-in Phase: Avelumab 70 mg Q2W	99.5	± 0.01
Lead-in Phase: Avelumab 350 mg Q2W	97.7	± 0.02
Lead-in Phase: Avelumab 500 mg Q3W	97.6	± 0.03
Lead-in Phase: Avelumab 500 mg Q2W	99.7	± 0.00
Lead-in Phase: Avelumab 10 mg/kg Q2W	97.8	± 0.03

Lead-in Phase: Percent Target Occupancy (CD14+ Monocytes) at Day 1 of Cycle 2 Primary · Day 1 of Cycle 2

Target occupancy on peripheral blood CD14+ T-cells by avelumab was investigated in human blood in vitro by flow cytometry.

Group	Value	95% CI
Lead-in Phase: Avelumab 70 mg Q2W	96.3	± 0.04
Lead-in Phase: Avelumab 350 mg Q2W	96.2	± 0.08
Lead-in Phase: Avelumab 500 mg Q3W	97.0	± 0.04
Lead-in Phase: Avelumab 500 mg Q2W	97.3	± 0.05
Lead-in Phase: Avelumab 10 mg/kg Q2W	98.8	± 0.02

Lead-in Phase: Percent Target Occupancy (CD3+ T-Cells) at Day 2 of Cycle 1 Primary · Day 2 of Cycle 1

Target occupancy on peripheral blood CD3+ T-cells by avelumab was investigated in human blood in vitro by flow cytometry.

Group	Value	95% CI
Lead-in Phase: Avelumab 70 mg Q2W	99.0	± 0.01
Lead-in Phase: Avelumab 350 mg Q2W	99.0	± 0.02
Lead-in Phase: Avelumab 500 mg Q3W	96.8	± 0.05
Lead-in Phase: Avelumab 500 mg Q2W	99.7	± 0.01
Lead-in Phase: Avelumab 10 mg/kg Q2W	89.8	± 0.22

Lead-in Phase: Percent Target Occupancy (CD3+ T-Cells) at Day 1 of Cycle 2 Primary · Day 1 of Cycle 2

Target occupancy on peripheral blood CD3+ T-cells by avelumab was investigated in human blood in vitro by flow cytometry.

Group	Value	95% CI
Lead-in Phase: Avelumab 70 mg Q2W	81.7	± 0.37
Lead-in Phase: Avelumab 350 mg Q2W	91.9	± 0.14
Lead-in Phase: Avelumab 500 mg Q3W	99.1	± 0.02
Lead-in Phase: Avelumab 500 mg Q2W	99.7	± 0.01
Lead-in Phase: Avelumab 10 mg/kg Q2W	98.7	± 0.01

Lead-in Phase: Area Under the Plasma Concentration-Time Profile From Time Zero to Extrapolated Infinity (AUC0-inf) of Avelumab After Single Dose Primary · pre-dose, 1, 6, 24, 144, and 312 hours post-dose on Day 1 of Cycle 1

AUC(0-inf) was defined as area under the plasma concentration-time profile from time zero to extrapolated infinity AUC(0-inf), after single dose.

Group	Value	95% CI
Lead-in Phase: Avelumab 70 mg Q2W	2588	± 59
Lead-in Phase: Avelumab 350 mg Q2W	8600	± 40
Lead-in Phase: Avelumab 500 mg Q3W	15887	± 29
Lead-in Phase: Avelumab 500 mg Q2W	17647	± 55
Lead-in Phase: Avelumab 10 mg/kg Q2W	23789	± 61

Lead-in Phase: Maximum Observed Plasma Concentration (Cmax) of Avelumab After Single Dose Primary · pre-dose, 1, 6, 24, 144, and 312 hours post-dose on Day 1 of Cycle 1

Group	Value	95% CI
Lead-in Phase: Avelumab 70 mg Q2W	24.0	± 35
Lead-in Phase: Avelumab 350 mg Q2W	68.4	± 33
Lead-in Phase: Avelumab 500 mg Q3W	126	± 15
Lead-in Phase: Avelumab 500 mg Q2W	143	± 24
Lead-in Phase: Avelumab 10 mg/kg Q2W	271	± 16

Lead-in Phase: Maximum Observed Plasma Concentration (Cmax) of Avelumab After Multiple Dose Primary · pre-dose, 1, 6, 24, 144, and 312 hours post-dose on Day 1 of Cycle 2

Group	Value	95% CI
Lead-in Phase: Avelumab 70 mg Q2W	26.1	± 21
Lead-in Phase: Avelumab 350 mg Q2W	78.7	± 19
Lead-in Phase: Avelumab 500 mg Q3W	135	± 8
Lead-in Phase: Avelumab 500 mg Q2W	195	± 46
Lead-in Phase: Avelumab 10 mg/kg Q2W	273	± 22

Lead-in Phase: Area Under the Plasma Concentration-Time Profile From Time Zero (Pre-Dose) to the Next Dose (AUC0-tau) of Avelumab After Single Dose Primary · pre-dose, 1, 6, 24, 144, and 312 hours post-dose on Day 1 of Cycle 1

AUCtau was defined as area under the plasma concentration-time profile from time zero (pre-dose) to the next dose (AUC0-tau) of avelumab, after single dose.

Group	Value	95% CI
Lead-in Phase: Avelumab 70 mg Q2W	1933	± 64
Lead-in Phase: Avelumab 350 mg Q2W	8450	± 28
Lead-in Phase: Avelumab 500 mg Q3W	15392	± 27
Lead-in Phase: Avelumab 500 mg Q2W	15436	± 38
Lead-in Phase: Avelumab 10 mg/kg Q2W	23780	± 54

Lead-in Phase: Area Under the Plasma Concentration-Time Profile From Time Zero (Pre-Dose) to the Next Dose (AUC0-tau) of Avelumab After Multiple Dose Primary · pre-dose, 1, 6, 24, 144, and 312 hours post-dose on Day 1 of Cycle 2

AUCtau was defined as area under the plasma concentration-time profile from time zero (pre-dose) to the next dose (AUC0-tau) of avelumab, after multiple dose.

Group	Value	95% CI
Lead-in Phase: Avelumab 70 mg Q2W	2067	± 6
Lead-in Phase: Avelumab 350 mg Q2W	8789	± 39
Lead-in Phase: Avelumab 500 mg Q3W	19173	± 23
Lead-in Phase: Avelumab 500 mg Q2W	21053	± 47
Lead-in Phase: Avelumab 10 mg/kg Q2W	27196	± 59

Lead-in Phase: Terminal Elimination Half-Life (t1/2) of Avelumab After Single Dose Primary · pre-dose, 1, 6, 24, 144, and 312 hours post-dose on Day 1 of Cycle 1

Terminal elimination half-life is the time measured for the plasma concentration to decrease by one half of avelumab, after single dose.

Group	Value	95% CI
Lead-in Phase: Avelumab 70 mg Q2W	3.49	± 28
Lead-in Phase: Avelumab 350 mg Q2W	3.25	± 44
Lead-in Phase: Avelumab 500 mg Q3W	4.04	± 23
Lead-in Phase: Avelumab 500 mg Q2W	4.38	± 39
Lead-in Phase: Avelumab 10 mg/kg Q2W	3.88	± 38

Lead-in Phase: Terminal Elimination Half-Life (t1/2) of Avelumab After Multiple Dose Primary · pre-dose, 1, 6, 24, 144, and 312 hours post-dose on Day 1 of Cycle 2

Terminal elimination half-life is the time measured for the plasma concentration to decrease by one half of avelumab, after multiple dose.

Group	Value	95% CI
Lead-in Phase: Avelumab 70 mg Q2W	2.92	± 13
Lead-in Phase: Avelumab 350 mg Q2W	3.43	± 43
Lead-in Phase: Avelumab 500 mg Q3W	4.62	± 17
Lead-in Phase: Avelumab 500 mg Q2W	4.59	± 36
Lead-in Phase: Avelumab 10 mg/kg Q2W	4.23	± 37

Lead-in Phase: Time to Attain Maximum Observed Plasma Concentration (Tmax) of Avelumab After Single Dose Primary · pre-dose, 1, 6, 24, 144, and 312 hours post-dose on Day 1 of Cycle 1

Time to reach maximum observed plasma concentration of avelumab, after single dose.

Group	Value	95% CI
Lead-in Phase: Avelumab 70 mg Q2W	1.13	1.00 – 1.22
Lead-in Phase: Avelumab 350 mg Q2W	21.60	5.78 – 25.10
Lead-in Phase: Avelumab 500 mg Q3W	1.99	1.23 – 24.30
Lead-in Phase: Avelumab 500 mg Q2W	1.59	1.17 – 2.00
Lead-in Phase: Avelumab 10 mg/kg Q2W	1.50	1.17 – 6.08

Adverse events — posted to ClinicalTrials.gov

Time frame: Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Lead-in Phase: Avelumab 70 mg Q2W

Serious: 5/6 (83%)

Deaths: 1/6

Lead-in Phase: Avelumab 350 mg Q2W

Serious: 2/6 (33%)

Deaths: 4/6

Lead-in Phase: Avelumab 500 mg Q3W

Serious: 3/6 (50%)

Deaths: 1/6

Lead-in Phase: Avelumab 500 mg Q2W

Serious: 2/6 (33%)

Deaths: 4/6

Lead-in Phase: Avelumab 10 mg/kg Q2W

Serious: 0/6 (0%)

Deaths: 3/6

Expansion Phase: Avelumab 70 mg, 500 mg Q2W

Serious: 2/3 (67%)

Deaths: 1/3

Serious adverse events (17 terms)

Reaction	System	Lead-in Phase: Avelumab 70…	Lead-in Phase: Avelumab 35…	Lead-in Phase: Avelumab 50…	Lead-in Phase: Avelumab 50…	Lead-in Phase: Avelumab 10…	Expansion Phase: Avelumab …
Lung infection	Infections and infestations	—	—	—	—	—	—
Infusion related reaction	Injury, poisoning and procedural complications	—	—	—	—	—	—
Encephalitis	Infections and infestations	—	—	—	—	—	—
Respiratory syncytial virus infection	Infections and infestations	—	—	—	—	—	—
Post procedural haemorrhage	Injury, poisoning and procedural complications	—	—	—	—	—	—
Graft versus host disease in liver	Immune system disorders	—	—	—	—	—	—
Immune thrombocytopenic purpura	Blood and lymphatic system disorders	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—
Body temperature increased	Investigations	—	—	—	—	—	—
C-reactive protein increased	Investigations	—	—	—	—	—	—
Dysarthria	Nervous system disorders	—	—	—	—	—	—
Hemiparesis	Nervous system disorders	—	—	—	—	—	—
Pneumonitis	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—
Orthostatic hypotension	Vascular disorders	—	—	—	—	—	—
Condition aggravated	General disorders	—	—	—	—	—	—
Disease progression	General disorders	—	—	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—

Other adverse events (143 terms — click to expand)

Reaction	System	Lead-in Phase: Avelumab 70…	Lead-in Phase: Avelumab 35…	Lead-in Phase: Avelumab 50…	Lead-in Phase: Avelumab 50…	Lead-in Phase: Avelumab 10…	Expansion Phase: Avelumab …
Nausea	Gastrointestinal disorders	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—
Abdominal distension	Gastrointestinal disorders	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—
Rhinitis	Infections and infestations	—	—	—	—	—	—
Infusion related reaction	Injury, poisoning and procedural complications	—	—	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—	—	—	—
Blood alkaline phosphatase increased	Investigations	—	—	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—	—	—
Muscle spasms	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—
Epistaxis	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—
Night sweats	Skin and subcutaneous tissue disorders	—	—	—	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—
Lymph node pain	Blood and lymphatic system disorders	—	—	—	—	—	—
Lymphadenopathy	Blood and lymphatic system disorders	—	—	—	—	—	—
Neutropenia	Blood and lymphatic system disorders	—	—	—	—	—	—
Thrombocytopenia	Blood and lymphatic system disorders	—	—	—	—	—	—
Tachycardia	Cardiac disorders	—	—	—	—	—	—
Ear pain	Ear and labyrinth disorders	—	—	—	—	—	—
Vertigo	Ear and labyrinth disorders	—	—	—	—	—	—
Adrenal insufficiency	Endocrine disorders	—	—	—	—	—	—
Hypopituitarism	Endocrine disorders	—	—	—	—	—	—
Iritis	Eye disorders	—	—	—	—	—	—
Vision blurred	Eye disorders	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—
Dry mouth	Gastrointestinal disorders	—	—	—	—	—	—
Dysphagia	Gastrointestinal disorders	—	—	—	—	—	—
Flatulence	Gastrointestinal disorders	—	—	—	—	—	—
Gingival bleeding	Gastrointestinal disorders	—	—	—	—	—	—
Gingival pain	Gastrointestinal disorders	—	—	—	—	—	—
Lip exfoliation	Gastrointestinal disorders	—	—	—	—	—	—
Lip swelling	Gastrointestinal disorders	—	—	—	—	—	—

Most-reported serious reactions: Lung infection, Infusion related reaction, Encephalitis, Respiratory syncytial virus infection, Post procedural haemorrhage, Graft versus host disease in liver, Immune thrombocytopenic purpura, Pyrexia.

Data from ClinicalTrials.gov NCT02603419 adverse events section.

Sponsor's own description

This is a Phase 1b, open-label, multi-center study comprising a lead-in phase and an expansion phase. The lead-in phase is a multiple-dose, randomized, parallel-arm, pharmacokinetic and pharmacodynamic study of avelumab as a single agent in adult patients with cHL. Patients enrolled in the lead-in phase of this study are required to have relapsed following a prior autologous or allogeneic HSCT, or to be ineligible for HSCT. Based on the preliminary TO, safety, and efficacy results from the lead-in phase, the expansion phase will evaluate the anti-tumor activity and safety of single-agent avelumab utilizing an intra-patient dose escalation paradigm based on two of the dosing regimens studied in the lead-in phase in 40 cHL patients in whom an allogeneic HSCT has failed.

Publications & conference data

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

Immune checkpoint blockade and CAR-T cell therapy in hematologic malignancies.
Wang H, Kaur G, Sankin AI, Chen F, et al · · 2019 · cited 138× · PMID 31186046 · DOI 10.1186/s13045-019-0746-1
Checkpoint inhibitors in hematological malignancies.
Ok CY, Young KH. · · 2017 · cited 93× · PMID 28482851 · DOI 10.1186/s13045-017-0474-3
Immune checkpoint blockade for hematologic malignancies: a review.
Pianko MJ, Liu Y, Bagchi S, Lesokhin AM. · · 2017 · cited 48× · PMID 28529947 · DOI 10.21037/sci.2017.03.04
Monoclonal Antibody Therapies for Hematological Malignancies: Not Just Lineage-Specific Targets.
Cuesta-Mateos C, Alcaraz-Serna A, Somovilla-Crespo B, Muñoz-Calleja C. · · 2017 · cited 39× · PMID 29387053 · DOI 10.3389/fimmu.2017.01936
Transplant strategies in relapsed/refractory Hodgkin lymphoma.
Shah GL, Moskowitz CH. · · 2018 · cited 35× · PMID 29500170 · DOI 10.1182/blood-2017-09-772673
Targeting the programmed death-1 pathway in lymphoid neoplasms.
Ok CY, Young KH. · · 2017 · cited 32× · PMID 28242522 · DOI 10.1016/j.ctrv.2017.01.009
The Role of Immune Checkpoint Inhibitors in Classical Hodgkin Lymphoma.
Meti N, Esfahani K, Johnson NA. · · 2018 · cited 29× · PMID 29914088 · DOI 10.3390/cancers10060204
PD-L1 inhibitors in the pipeline: Promise and progress.
Vanella V, Festino L, Strudel M, Simeone E, et al · · 2017 · cited 28× · PMID 29296516 · DOI 10.1080/2162402x.2017.1365209

Verify or expand the search:

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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 NCT02603419 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 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 Pfizer
Last refreshed: 24 April 2020

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/NCT02603419.

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