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NCT01827111

Phase II Study of Abraxane Plus Ipilimumab in Patients With Metastatic Melanoma

Completed Phase 2 Results posted Last updated 8 February 2022
What this trial tests

Phase 2 trial testing ABI-007 in Melanoma in 21 participants. Completed in 21 September 2020.

Timeline
25 April 2013
Primary endpoint
21 September 2020
21 September 2020

Quick facts

Lead sponsorM.D. Anderson Cancer Center
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment21
Start date25 April 2013
Primary completion21 September 2020
Estimated completion21 September 2020
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

M.D. Anderson Cancer Center — full company profile →

Who can join

Adults 12 to 70, any sex, with Melanoma. 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.

Median Overall Survival Response to Abraxane Plus Ipilimumab Therapy Primary · From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 50 months

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v 1.1) was used. Complete Response (CR)= Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm, no new lesions; Partial Response (PR)= At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

GroupValue95% CI
ABI-007 + Ipilimumab24.90 – 49
Median Progression Free Survival Primary · From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 50 months

Progression-free survival (PFS) is the time from random assignment in a clinical trial to disease progression or death from any cause.

GroupValue95% CI
ABI-007 + Ipilimumab100.0 – 27.2

Adverse events — posted to ClinicalTrials.gov

Time frame: up to 50 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

ABI-007 + Ipilimumab
Serious: 2/18 (11%)
Deaths: 0/18

Serious adverse events (11 terms)

ReactionSystemABI-007 + Ipilimumab
HypophysitisEndocrine disorders
ColitisGastrointestinal disorders
FeverGeneral disorders
Wound InfectionInvestigations
NauseaGastrointestinal disorders
VomitingGastrointestinal disorders
DyspneaRespiratory, thoracic and mediastinal disorders
Lung InfectionRespiratory, thoracic and mediastinal disorders
HypotensionCardiac disorders
HyponatremiaMetabolism and nutrition disorders
Macular CystoidEye disorders
Other adverse events (25 terms — click to expand)

ReactionSystemABI-007 + Ipilimumab
AlopeciaSkin and subcutaneous tissue disorders
FatigueGeneral disorders
RashSkin and subcutaneous tissue disorders
NeuropathyNervous system disorders
ArthralgiaMusculoskeletal and connective tissue disorders
DiarrheaGastrointestinal disorders
PruritisSkin and subcutaneous tissue disorders
MyalgiaMusculoskeletal and connective tissue disorders
PainGeneral disorders
AnorexiaMetabolism and nutrition disorders
NauseaGastrointestinal disorders
TransaminitisInvestigations
AnemiaBlood and lymphatic system disorders
VomitingGastrointestinal disorders
ConstipationGastrointestinal disorders
HeadacheNervous system disorders
HypertensionCardiac disorders
ChillsGeneral disorders
FeverGeneral disorders
HypothyroidismEndocrine disorders
MucositisGastrointestinal disorders
Elevated BilirubinInvestigations
Elevated CreatinineInvestigations
HypophysitisEndocrine disorders
ThrombocytopeniaBlood and lymphatic system disorders

Most-reported serious reactions: Hypophysitis, Colitis, Fever, Wound Infection, Nausea, Vomiting, Dyspnea, Lung Infection.

Data from ClinicalTrials.gov NCT01827111 adverse events section.

Sponsor's own description

The goal of this clinical research study is to learn if the combination of ipilimumab and ABI-007 (abraxane) can help to control metastatic melanoma. The safety of this drug combination will also be studied. Ipilimumab is designed to increase the immune system's ability to fight cancer. Abraxane is designed to stop cancer cells from making new DNA (the genetic material of cells). This may stop the cancer cells from dividing into new cells.

Publications & conference data

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

  1. Trial Watch: Immunostimulatory monoclonal antibodies in cancer therapy.
    Aranda F, Vacchelli E, Eggermont A, Galon J, et al · · 2014 · cited 92× · PMID 24701370 · DOI 10.4161/onci.27297
  2. Limitations and opportunities for immune checkpoint inhibitors in pediatric malignancies.
    Park JA, Cheung NV. · · 2017 · cited 81× · PMID 28622628 · DOI 10.1016/j.ctrv.2017.05.006
  3. A randomized, controlled phase III trial of nab-Paclitaxel versus dacarbazine in chemotherapy-naïve patients with metastatic melanoma.
    Hersh EM, Del Vecchio M, Brown MP, Kefford R, et al · · 2015 · cited 74× · PMID 26410620 · DOI 10.1093/annonc/mdv324
  4. <i>nab</i>-Paclitaxel as a potential partner with checkpoint inhibitors in solid tumors.
    Soliman HH. · · 2017 · cited 65× · PMID 28053544 · DOI 10.2147/ott.s122974
  5. Immune checkpoint blockade in cancer treatment: a double-edged sword cross-targeting the host as an "innocent bystander".
    Gelao L, Criscitiello C, Esposito A, Goldhirsch A, et al · · 2014 · cited 56× · PMID 24594636 · DOI 10.3390/toxins6030914
  6. Novel induction of CD40 expression by tumor cells with RAS/RAF/PI3K pathway inhibition augments response to checkpoint blockade.
    Yan C, Saleh N, Yang J, Nebhan CA, et al · · 2021 · cited 34× · PMID 34092233 · DOI 10.1186/s12943-021-01366-y
  7. The past, present and future of immunotherapy against tumor.
    Jiang T, Zhou C. · · 2015 · cited 34× · PMID 26207213 · DOI 10.3978/j.issn.2218-6751.2015.01.06
  8. Nanotechnology Addressing Cutaneous Melanoma: The Italian Landscape.
    Battaglia L, Scomparin A, Dianzani C, Milla P, et al · · 2021 · cited 9× · PMID 34683910 · DOI 10.3390/pharmaceutics13101617

Verify or expand the search:

Other trials of ABI-007

Trials testing the same drug.

Other recruiting trials for Melanoma

Currently open trials in the same condition.

Other M.D. Anderson Cancer Center trials

Trials by the same sponsor.

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