Evidence map›Paper›PMID 38309722›Full record

Trial reportJournal for immunotherapy of cancer2024

Phase 1/2 study of monalizumab plus durvalumab in patients with advanced solid tumors.

Sandip P Patel, Teresa Alonso-Gordoa, Susana Banerjee, Ding Wang, Jarushka Naidoo, Nathan E Standifer, Doug C Palmer, Lin-Yang Cheng, Panagiotis Kourtesis, Maria L Ascierto and 4 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIClinical Trial, Phase I
In one paragraph

Trial report in Journal for immunotherapy of cancer, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02671435 (A Phase 1/2 Study of Durvalumab and Monalizumab in Adult Subjects With Select Advanced Solid Tumors), which is not on this map. Cited by 40 papers.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed
11.3field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02671435 phase1 / phase2active not recruitingnot on this map

A Phase 1/2 Study of Durvalumab and Monalizumab in Adult Subjects With Select Advanced Solid Tumors

TypeinterventionalSponsorMedImmune LLCRan2016 to 2027Enrolled383ConditionsAdvanced Solid TumorsArmsMonalizumab, Durvalumab, Cetuximab, mFOLFOX6, Bevacizumab
3 · Its place in the literature

Who cites it

40 citing papers in PubMed, 47 citations in OpenAlex.

  1. Review
  2. Asthenia in cancer patients receiving immune checkpoint Inhibitors (ICIs): the MOUSEION-11 systematic review and meta-analysis.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
    Review
  3. Review
  4. Review
  5. Review
  6. Article
  7. Review
  8. NKG2A inhibition promotes NK cell-CD8Nature communications · 2026
    Article
  9. Review
  10. Article
  11. The CD94/NKG2A-HLA-E Axis as a Target in Cancer Immunotherapy: A Critical Perspective.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
    Review
  12. Article
  13. Review
  14. Review
  15. Review
  16. Article
  17. Review
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  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors at 10 institutions in 3 countries.

Sandip P PatelUniversity of California San Diego, Moores Cancer Center, San Diego, California, USA spatel@ucsd.edu.ORCID 0000-0002-8387-4840
Teresa Alonso-GordoaHospital Universitario Ramón y Cajal, Madrid, Spain.
Susana BanerjeeRoyal Marsden NHS Foundation Trust and Institute of Cancer Research, London, UK.
Ding WangHenry Ford Health System, Detroit, Michigan, USA.
Jarushka NaidooJohns Hopkins Medicine, Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, USA.ORCID 0000-0002-3470-8686
Nathan E StandiferBioPharmaceuticals Research and Development, AstraZeneca, South San Francisco, California, USA.
Doug C PalmerOncology Research and Development, AstraZeneca, Gaithersburg, Maryland, USA.
Lin-Yang ChengOncology Research and Development, AstraZeneca, Gaithersburg, Maryland, USA.
Panagiotis KourtesisOncology Research and Development, AstraZeneca, Gaithersburg, Maryland, USA.
Maria L AsciertoOncology Research and Development, AstraZeneca, Gaithersburg, Maryland, USA.
Mayukh DasOncology Research and Development, AstraZeneca, Gaithersburg, Maryland, USA.
Jennifer R DiamondUniversity of Colorado, Anschutz Medical Campus, Denver, Colorado, USA.
Matthew D HellmannMemorial Sloan Kettering Cancer Center, New York, New York, USA.
Benedito A CarneiroLegorreta Cancer Center at Brown University, Lifespan Cancer Institute, Providence, Rhode Island, USA.
AstraZeneca (United States) · USBloomberg (United States) · USBrown University · USHenry Ford Health System · USHospital Universitario Ramón y Cajal · ESMemorial Sloan Kettering Cancer Center · USNGM Biopharmaceuticals (United States) · USRoyal Marsden NHS Foundation Trust · GBUniversity of California San Diego · USUniversity of Colorado Anschutz Medical Campus · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI SELWYN M VICKERS · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

backgroundThe combination of monalizumab (anti-NKG2A/CD94) and durvalumab (anti-programmed death ligand-1) may promote antitumor immunity by targeting innate and adaptive immunity. This phase 1/2 study of monalizumab and durvalumab evaluated safety, antitumor activity, and pharmacodynamics in patients with advanced solid tumors. MAIN BODY: Immunotherapy-naïve patients aged ≥18 years with advanced disease, Eastern Cooperative Oncology Group performance status of 0-1, and 1-3 prior lines of systemic therapy in the recurrent/metastatic setting were enrolled. In part 1 (dose escalation), patients received durvalumab 1500 mg every 4 weeks (Q4W) with increasing doses of monalizumab Q2W/Q4W (n=15). Dose expansion in part 1 included patients with cervical cancer (n=15; durvalumab 1500 mg Q4W and monalizumab 750 mg Q2W) or metastatic microsatellite stable (MSS)-colorectal cancer (CRC) (n=15; durvalumab 1500 mg Q4W and monalizumab 750 mg Q4W). In part 2 (dose expansion), patients with MSS-CRC (n=40), non-small cell lung cancer (NSCLC; n=20), MSS-endometrial cancer (n=40), or ovarian cancer (n=40) received durvalumab 1500 mg Q4W and monalizumab 750 mg Q2W. The primary endpoint was safety. Secondary endpoints included antitumor activity per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST v1.1). Exploratory analyses included assessment of T-cell and natural killer (NK) cell activation and proliferation in peripheral blood and the tumor microenvironment (TME). The study enrolled 185 patients (part 1, 45; part 2, 140). No dose-limiting toxicities were observed and the maximum tolerated dose was not reached. In part 2, the most common treatment-related adverse events were fatigue (12.1%), asthenia (9.3%), diarrhea (9.3%), pruritus (7.9%), and pyrexia (7.1%). In the expansion cohorts, response rates were 0% (cervical), 7.7% (MSS-CRC), 10% (NSCLC), 5.4% (ovarian), and 0% (MSS-endometrial). Sustained NK cell activation, CD8

conclusionsAlthough efficacy was modest, monalizumab plus durvalumab was well tolerated and encouraging immune activation was observed in the peripheral blood and TME. TRIAL REGISTRATION NUMBER: NCT02671435.

Indexed as

Antibodies, MonoclonalAntibodies, Monoclonal, HumanizedCarcinoma, Non-Small-Cell LungLung NeoplasmsAdolescentAdultFemaleHumansLigandsTumor MicroenvironmentAntibodies, MonoclonalAntibodies, Monoclonal, HumanizeddurvalumabLigandsmonalizumabAdaptive ImmunityImmunity, InnateNatural Killer T-CellsProgrammed Cell Death 1 ReceptorTumor Microenvironment

Identifiers

PMID38309722
PMCPMC10840023
OpenAlexW4391512597

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.