West Cancer Center

ADVANCED TUMORS; Metastatic; NSCLC, SCCHN, DLBCL; OX-40 agonist; "D4981C00001"

A phase 1b/2, open-label study to evaluate the safety and tolerability of MEDI6469 in combination with ummune therapeutic agents or therapeutic monoclonal antibodies in subjects with selected advanced solid tumors or aggressive B-cell lymphomas

Title

MedImmune D4981C00001

Study Title

Site Link

NCT02205333

Malignancy

z- Diffuse large B-cell lymphoma (DLBCL)

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

>2nd line (no standard therapy)

Investigational Agent

MEDI6469; rituximab

Drug Class

OX-40 agonist; anti-CD20 Ab

Daruka Mahadevan, MD, PhD

Sponsor

MedImmune

Phase

Phase 1

Status

Closed to Accrual

Key Eligibility Criteria

http://www.clinicaltrials.gov/ct2/show/NCT02205333

Key Eligibility Criteria Details

DLBCL metastatic/refractory to standard therapy
ECOG PS 0-1

Hgb>9, ANC>1500, plt>100K
bili<1.5xULN, AST/ALT<2.5xULN, Cr<2
CNS mets allowed only if adequately treated, off high-dosesteroids, no concurrent tx, >28 days after radiation without progression
No prior exposure to immunotherapy
No immunosuppressive medications (>_10 mg pred/day)
No autoimmune disease (except hypothyroidism, vitiligo, psoriasis)
No receipt of live attenuated vaccine within 28 days

Objective

Primary: MTD, safety. Secondary: Antitumor activity (ORR, Dz control, DOR, PFS, OS), PK, Immunogenicity

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

DLBCL

Dosing Frequency

per protocol

Control Agents

N/A

Study Protocol

Randomized