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Safety And Efficacy Study Of Avelumab Plus Chemotherapy With Or Without Other Anti-Cancer Immunotherapy Agents In Patients With Advanced Malignancies

Last updated on December 5, 2018

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Study Location
University of Arizona Cancer Center - North Campus
Tucson, Arizona, 85719 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Non-small Cell Lung Cancer, Urothelial Cancer
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

• Eligible tumor type diagnosis

– Non-squamous NSCLC

– Cisplatin-eligible UC

• No prior systemic treatment for unresectable locally advanced or metastatic disease for given tumor type. If prior therapy in adjuvant or neoadjuvant setting, disease free interval must be > 6 months for NSCLC and > 12 months for UC.

• Measurable disease by RECIST v1.1 with ≥ 1 measurable lesion

• Available tumor specimen at baseline (archived ≤12 months or de novo biopsy)

• Age ≥ 18 years

• ECOG 0 or 1

• Adequate hepatic, renal, and bone marrow function per protocol.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
Trial Details
Administration
The form in which the study drug will be delivered to the patient's body.
Intravenous injections
Placebo
A placebo often looks like the investigational medication, but it has no active ingredient in it.
A placebo is not used in this trial
Prior Approval
The study drug has not been approved yet.
Post-Trial Access to Study Drug
Possible
NCT03317496
Pfizer
Recruiting
Safety And Efficacy Study Of Avelumab Plus Chemotherapy With Or Without Other Anti-Cancer Immunotherapy Agents In Patients With Advanced Malignancies

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Safety And Efficacy Study Of Avelumab Plus Chemotherapy With Or Without Other Anti-Cancer Immunotherapy Agents In Patients With Advanced Malignancies
A Multicenter, Open-label, Phase 1b/2 Study To Evaluate Safety And Efficacy Of Avelumab (msb0010718c) In Combination With Chemotherapy With Or Without Other Anti-cancer Immunotherapies As First-line Treatment In Patients With Advanced Malignancies
This is a Phase 1b/2, open label, multicenter, safety and clinical activity study of avelumab in combination with chemotherapy as first-line treatment of adult patients with locally advanced or metastatic solid tumors. Initially, avelumab will be evaluated in combination with pemetrexed and carboplatin in patients with advanced non-squamous non-small cell lung cancer (NSCLC) (Cohort A1) and in combination with gemcitabine and cisplatin in patients with cisplatin-eligible urothelial (bladder) cancer (UC) (Cohort A2). As more information is learned about other anti-cancer immunotherapy agents, in future portions of the study, avelumab may be combined with chemotherapy and other anti-cancer immunotherapy agents in patients with these same or different tumor types.

This is a Phase 1b/2, open label, multicenter, safety, clinical activity, pharmacokinetic (PK), and pharmacodynamics (PD) study of avelumab in combination with chemotherapy with or without other anti-cancer immunotherapies, as first-line treatment of adult patients with locally advanced or metastatic solid tumors. Initially, avelumab will be evaluated in combination with pemetrexed and carboplatin in patients with advanced non-squamous non-small cell lung cancer (NSCLC) (Cohort A1) and with gemcitabine and cisplatin in patients with cisplatin-eligible urothelial cancer (UC) (Cohort A2).

Given the growing preclinical and clinical indications that combinations of anti-cancer immunotherapies potentially improve patient outcomes compared to results seen with single agents, in portions of the study to be added in the future, avelumab will be evaluated in combination with both standard-of-care chemotherapy and other anti-cancer immunotherapies in patients with advanced malignancies. Each cohort in the study will consist of a Phase 1b lead-in portion to evaluate safety and a Phase 2 cohort expansion to evaluate safety and efficacy.

In the Phase 1b safety lead-in portion, up to 12 patients will be enrolled into each cohort and evaluated for dose-limiting toxicities (DLT) during the first 2 cycles of treatment. If investigational products administration in a cohort is deemed safe in the Phase 1b lead-in, enrollment will be expanded into the Phase 2 cohort expansion. Up to approximately 40 patients in each cohort (including those enrolled in the Phase 1b lead-in and those enrolled in the Phase 2 cohort expansion) will be enrolled and treated with avelumab plus chemotherapy in the initial portion of the study and, in future portions of the study, with avelumab plus chemotherapy with or without other anti-cancer immunotherapies.

Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Non-small Cell Lung Cancer
  • Urothelial Cancer
  • Drug: Avelumab in combination with pemetrexed / carboplatin
    Avelumab Pemetrexed Carboplatin
  • Drug: Avelumab in combination with gemcitabine / cisplatin.
    Avelumab Gemcitabine Cisplatin
  • Experimental: Group A Cohort A1
    Non-squamous non-small cell lung cancer (NSCLC) patients treated with avelumab plus pemetrexed/carboplatin
    Intervention: Drug: Avelumab in combination with pemetrexed / carboplatin
  • Experimental: Group A Cohort A2
    Cisplatin-eligible urothelial cancer patients treated with avelumab plus gemcitabine/cisplatin
    Intervention: Drug: Avelumab in combination with gemcitabine / cisplatin.
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
80
November 18, 2020
November 19, 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Histological diagnosis of locally advanced (primary or recurrent) or metastatic solid tumor that is not amenable for treatment with curative intent as follows:

    • For all groups:
    • Measurable disease by RECIST v1.1 with at least 1 measurable lesion;
    • No prior systemic treatment for unresectable locally advanced or metastatic disease for the tumor type under study. If prior systemic chemotherapy treatment was given in the adjuvant or neo-adjuvant setting or as part of radiotherapy chemotherapy treatment, disease-free interval after stop of systemic treatment must be more than 6 months for non-squamous NSCLC and more than 12 months for UC;
    • Cohort A1: Non-squamous NSCLC, with no activating EGFR mutations, ALK or ROS1 translocations/rearrangements. If monotherapy pembrolizumab is available as a standard of care treatment option, patients must have a tumor proportion score (TPS) <50% for PD L1 (via the 22C3 pharmDx or the Ventana (SP263) PD L1 IHC assay).
    • Cohort A2: Transitional cell carcinoma of the urothelium including the bladder, urethra, renal pelvis, and ureter.
  2. ECOG performance status 0 or 1
  3. Estimated life expectancy of at least 90 days
  4. Adequate bone marrow, renal, and liver function
  5. Negative serum pregnancy test at screening
  6. Male and female patients able to have children must agree to use 2 highly effective methods of contraception throughout the study and for at least 90 days after last dose of chemotherapy or at least 30 days after last dose of avelumab, whichever is longer
  7. Signed and dated informed consent

Exclusion Criteria:

  1. Prior immunotherapy with any antibody or drug specifically targeting T cell co-stimulation or immune checkpoint pathways.
  2. Patients with known symptomatic central nervous system metastases requiring steroids.
  3. Diagnosis of other malignancy within 2 years prior to enrollment except adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the bladder, breast, or cervix, or low grade (Gleason ?6) prostate cancer
  4. Use of immunosuppressive medication at the time of enrollment
  5. Active or prior autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent.
  6. Prior organ transplantation including allogenic stem cell transplantation
  7. Active infection requiring systemic therapy
  8. Known history of HIV or AIDS
  9. Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening
  10. Administration of live vaccine within 4 weeks prior to study entry
  11. Known prior severe hypersensitivity to the investigational products or any component in their formulations,
  12. Known prior severe hypersensitivity to platinum-related compounds for all cohorts, to pemetrexed for patients enrolled in Cohort A1, and to gemcitabine for patients enrolled in Cohort A2
  13. Persisting toxicity related to prior therapy (NCI CTCAE v4.03 Grade > 1)
  14. Known history of colitis, inflammatory bowel disease, pneumonitis, pulmonary fibrosis.
  15. Ongoing cardiac dysrhythmias of NCI CTCAE v4.03 Grade 2 or prolongation of the QTcF interval to >480 msec.
  16. Clinically significant (ie, active) cardiovascular disease: cerebral vascular accident/stroke (<6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure, or serious cardiac arrhythmia requiring medication.
  17. Major surgery ?28 days or major radiation therapy ?14 days prior to enrollment.
  18. Participation in other studies involving investigational drug(s) within 28 days prior to study entry.
  19. Concurrent treatment with a prohibited medication.
  20. Other acute or chronic medical or psychiatric condition
  21. Pregnant female patients; breastfeeding female patients; fertile male patients and female patients of childbearing potential who are unwilling or unable to use 2 highly effective methods of contraception as outlined in this protocol for the duration of the study and for at least 90 days after the last dose of chemotherapy or at least 30 days after the last dose of avelumab, whichever is longer.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
United States
 
 
NCT03317496
B9991023
B9991023 ( Other Identifier: Pfizer )
2017-001741-27 ( EudraCT Number )
JAVELIN CHEMOTHERAPY MEDLEY ( Other Identifier: Alias Study Number )
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Yes
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/da...
URL: http://
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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