Evidence map›Paper›PMID 28031816›Full record

ArticleJournal for immunotherapy of cancer2016

A phase IB study of ipilimumab with peginterferon alfa-2b in patients with unresectable melanoma.

Andrew S Brohl, Nikhil I Khushalani, Zeynep Eroglu, Joseph Markowitz, Ram Thapa, Y Ann Chen, Ragini Kudchadkar, Jeffrey S Weber

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Journal for immunotherapy of cancer, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01496807 (A Phase Ib Study of Yervoy With Sylatron for Patients With Unresectable Stages IIIB/C/IV Melanoma), which is not on this map. Cited by 18 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 2 pooled it
2.0field-weighted citation impact, top 11% 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.

NCT01496807 phase1completednot on this map

A Phase Ib Study of Yervoy With Sylatron for Patients With Unresectable Stages IIIB/C/IV Melanoma

TypeinterventionalSponsorH. Lee Moffitt Cancer Center and Research InstituteRan2012 to 2016Enrolled31ConditionsMelanomaArmsSylatron, Yervoy
3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 2 syntheses or guidelines pooled it, 25 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. E3611-A Randomized Phase II Study of Ipilimumab at 3 or 10 mg/kg Alone or in Combination with High-Dose Interferon-α2b in Advanced Melanoma.Clinical cancer research : an official journal of the American Association for Cancer Research · 2019
    Trial
  4. Review
  5. Review
  6. Targeting inflammation as cancer therapy.Journal of hematology & oncology · 2024
    Review
  7. Harnessing cytokines and chemokines for cancer therapy.Nature reviews. Clinical oncology · 2022
    Review
  8. Melanoma therapeutics: a literature review.Journal of biomedical research · 2022
    Article
  9. Article
  10. Cutaneous melanoma and the immunotherapy revolution (Review).International journal of oncology · 2020
    Review
  11. Review
  12. Article
  13. Review
  14. Melanoma treatment in review.ImmunoTargets and therapy · 2018
    Review
  15. Review
  16. Article
  17. Review
  18. 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

8 authors at 3 institutions in 2 countries.

Andrew S BrohlDepartment of Cutaneous Oncology, H. Lee Moffitt Cancer Center and Research Institute, 12902 Magnolia Drive, Tampa, FL 33612-9416 USA.
Nikhil I KhushalaniDepartment of Cutaneous Oncology, H. Lee Moffitt Cancer Center and Research Institute, 12902 Magnolia Drive, Tampa, FL 33612-9416 USA.
Zeynep ErogluDepartment of Cutaneous Oncology, H. Lee Moffitt Cancer Center and Research Institute, 12902 Magnolia Drive, Tampa, FL 33612-9416 USA.
Joseph MarkowitzDepartment of Cutaneous Oncology, H. Lee Moffitt Cancer Center and Research Institute, 12902 Magnolia Drive, Tampa, FL 33612-9416 USA.
Ram ThapaDepartment of Biostatistics and Bioinformatics, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL USA.
Y Ann ChenDepartment of Biostatistics and Bioinformatics, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL USA.
Ragini KudchadkarWinship Cancer Institute of Emory University, Atlanta, GA USA.
Jeffrey S WeberDepartment of Cutaneous Oncology, H. Lee Moffitt Cancer Center and Research Institute, 12902 Magnolia Drive, Tampa, FL 33612-9416 USA ; New York University Langone Medical Center, New York, NY USA.
Moffitt Cancer Center · USCancer Institute (WIA) · INNYU Langone Health · US

Funding

TRANSLATIONAL RESEARCHP30CA076292 · NCI · UNIVERSITY OF SOUTH FLORIDA · PI John L. Cleveland · 1998 to 2026
$93.5M
NCI NIH HHS P30 CA076292
6 · The paper itself

Abstract

backgroundIpilimumab and peginterferon alfa-2b are established systemic treatment options for melanoma that have distinct mechanisms of action. Given the need for improved therapies for advanced melanoma, we conducted an open-label, single institution, phase Ib study to assess the safety and tolerability of using these two agents in combination.

methodsStudy treatment consisted of ipilimumab given every 3 weeks, for a total of four infusions, concurrent with peginterferon alfa-2b administered subcutaneous weekly for a total of 12 weeks. This was followed by maintenance therapy with peginterferon alfa-2b administered subcutaneously weekly for up to 144 additional weeks. The study was designed as a two-stage dose escalation scheme with continuous dose-limiting toxicity monitoring during the induction phase.

resultsThirty one patients received at least 1 dose of study treatment and 30 were assessable for efficacy endpoints. We found that ipilimumab at 3 mg/kg dosing with peginterfeon alfa-2b at 2 μg/kg/week was the maximum tolerated dose of this combination. The incidence of grade 3 drug-related adverse events (AEs) was 45.2%. There were no grade 4/5 AEs. The overall response rate was 40% by immune-related response criteria. Median progression-free survival was 5.9 months. The median overall survival was not reached with at a median follow-up of 35.8 months.

conclusionsWe report that the combination of ipilimumab at 3 mg/kg dosing combined with peginterfeon alfa-2b at 2 μg/kg/week demonstrated an acceptable toxicity profile and a promising efficacy signal. Further study of this combination is warranted.

trial registrationClinicalTrials.gov identifier: NCT01496807, Registered December 19th, 2011.

Indexed as

Clinical trialImmunotherapyIpilimumabMelanomaPeginterferon alfa-2b

Identifiers

PMID28031816
PMCPMC5170897
OpenAlexW2550174762

What OpenQuestion holds

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LicenceCC BY
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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.