Recruiting
Phase 2

CAPTUR

Sponsor:

Canadian Cancer Trials Group

Code:

NCT03297606

Conditions

Lymphoma, Non-Hodgkin

Multiple Myeloma

Advanced Solid Tumors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Olaparib

Dasatinib

Nivolumab plus Ipilimumab

Axitinib

Bosutinib

Study Details

Brief summary:

Cancer drugs which target the effects of abnormal gene changes are called 'targeted therapies'. This study, called PM.1 or CAPTUR, will include some targeted therapies that are currently available. The purpose of this study is to find out what are the effects on a patient and their cancer when they are given a targeted therapy drug that is specific to an abnormal gene change in their cancer.

Conditions

Lymphoma, Non-Hodgkin

Multiple Myeloma

Advanced Solid Tumors

Study ID

NCT03297606

Start date

Mar 23, 2018

Status verified date

Mar, 2026

Completion date

Jan 31, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria: (screening step - non-drug specific)

  • Adult (≥ 18 yrs) patient with a histologically-proven incurable metastatic solid tumour (excluding primary brain tumours), multiple myeloma or B cell non-Hodgkin lymphoma (excluding CLL, SLL and HCL), for whom there is no standard treatment known to prolong life, or who has refused such treatment.
  • ECOG performance status 0-2.
  • Patients must have normal organ function as follows:

  • Absolute neutrophil count: ≥ 1.5 x 10\^9/L for solid tumours; ≥ 1.0 x 10\^9/L for neurologic malignancies
  • Platelets ≥ 75 x 10\^9/L (or ≥ 50 x 10\^9/L if bone marrow involvement by myeloma or lymphoma).
  • Total bilirubin ≤ 1.5 x UNL.
  • AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional upper limit of normal value unless liver metastases are present in which case they must be < 5 x ULN;
  • Serum creatinine ≤ 1.5 x UNL or calculated or measured creatinine clearance ≥ 50mg/min/1.73µ\^2
  • Patients must have measurable disease
  • Results must be available from tumour genomic or protein expression testing (if used to identify genetic variants), from one of the initiatives / groups listed in protocol Appendix VII. The test may have been performed on the primary tumour or a metastatic deposit (including bone marrow), or blood, in a diagnostic or research laboratory and must reveal a potentially actionable variant.
  • Patient consent (Main Study Consent for the screening step) must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to the screening step to document their willingness to participate
  • Patients must be accessible for treatment and follow-up. Patients registered on this trial must be treated and followed at the participating centre or a CCTG IND site. This implies there must be reasonable geographical limits (for example: 1 ½ hour's driving distance) placed on patients being considered for this trial.
  • Women/men of childbearing potential must have agreed to use a highly effective contraceptive method.

Exclusion Criteria: (screening step - non-drug specific)

  • Patients with prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen.
  • Patients with ongoing toxicity ≥ CTCAE grade 2, other than peripheral neuropathy or asymptomatic, corrected biochemical toxicities (e.g. hypothyroidism corrected by thyroid replacement), related to prior anti-tumour treatment. Patients with ongoing peripheral neuropathy of ≥ CTCAE grade 3 will be excluded.
  • Patients concurrently receiving any other anti-cancer therapy (cytotoxic, biologic, radiation, or hormonal other than for replacement) except for medications that are prescribed for supportive care but may potentially have an anti-cancer effect (e.g. megestrol acetate, bisphosphonates) or ongoing castration-intent therapy for prostate cancer. These medications must have been started ≥ one month prior to enrollment on this study. Patients may be on warfarin, low molecular weight heparin or direct factor Xa inhibitors, unless such therapies are prohibited by drug-specific ineligibility criteria.
  • Patients with known active progressive brain metastases. Patients with previously treated brain metastases are eligible, provided that the patient has not experienced a seizure or had a clinically significant change in neurological status within one month prior to screening. All patients with previously treated brain metastases must be stable (clinically and radiologically) for at least one month after completion of treatment and either off steroid treatment or only taking physiological doses of steroids prior to the screening step.
  • Patients with clinically significant pre-existing cardiac conditions, including uncontrolled or symptomatic angina, uncontrolled atrial or ventricular arrhythmias, or symptomatic congestive heart failure.
  • Patients with known left ventricular ejection fraction (LVEF) < 40%.
  • Patients with stroke (including TIA) or acute myocardial infarction within three months prior to the screening step.
  • Patients with acute gastrointestinal bleeding within one month prior to the screening step.
  • Patients with any other clinically significant medical condition which, in the opinion of the treating physician, makes it undesirable for the patient to participate in the study or which could jeopardize compliance with study requirements including, but not limited to: ongoing or active infection, significant uncontrolled hypertension, or severe psychiatric illness/social situations.
  • Lactating and nursing women
  • Patients who do not meet drug-specific eligibility requirements for the drug selected by the treating physician.

Study Design

Enrollment

720 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Group 1 - Arm CLOSED, no patients recruited

VEGFR1, VEGFR2, VEGFR3

experimental: Group 2 - Arm CLOSED, no patients recruited

BCR-ABL, SRC

experimental: Group 3 - Arm CLOSED

ALK, ROS1, MET

experimental: Group 4 - Arm CLOSED, no patients recruited

KIT, PDGFRA, PDGFRB, ABL1

experimental: Group 5 - Arm CLOSED

EGFR

experimental: Group 6 - Arm CLOSED

high mutation burden, POLE, POLD1

experimental: Group 7 - Arm CLOSED

BRCA1, BRCA2, mutations in HRD

experimental: Group 8 - Arm CLOSED

CDKN2A, CDK4, CCND1, SMARCA4

experimental: Group 9 Arm CLOSED

CSF1R, PDGFRA, PDGFRB,VEGFR1, VEGFR2, VEGFR3, KIT, FLT3, RET, FGFR1, FGFR2, FGFR3, VHL

experimental: Group 10 Arm CLOSED

AKT1, AKT2, AKT3, FBXW7, FLCN, mTOR, NF1, NF2, NTRK3, PIK3CA, PIK3R1, PTEN, RHEB, STK11, TSC1, TSC2

experimental: Group 11 - Arm CLOSED

ERBB2

experimental: Group 12 - Arm CLOSED

BRAFV600

experimental: Group 13 - Arm CLOSED

PTCH1, SMO

experimental: Group 14

ERBB2

Interventions

Olaparib

300mg taken twice daily

Dasatinib

100mg administered orally once daily

Nivolumab plus Ipilimumab

  • Combination Phase - 3mg/kg nivolumab administered as an intravenous infusion over 30 minutes every 3 weeks for the first 4 doses in combination with ipilmumab 1mg/kg administered intravenously over 30 minutes, followed by the single-agent phase.
  • Single-Agent Phase - 480mg nivolumab administered as an intravenous infusion over 30 minutes every 4 weeks.

Axitinib

5mg orally twice daily

Bosutinib

500mg orally once daily

Crizotinib

250mg orally twice daily

Palbociclib

125mg orally once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete cycle of 28 days

Sunitinib

50mg orally once daily on a schedule of 4 weeks on treatment followed by 2 weeks off

Temsirolimus

25mg infused over a 30-60 minute period once a week

Erlotinib

150mg orally, once daily

Trastuzumab plus Pertuzumab

Trastuzumab = 3-weekly dose schedule. The recommended initial loading dose is 8mg/kg administered as a 90-minute infusion followed by 3-weekly maintenance dose of 6mg/kg administered as 90-minute infusion.

Pertuzumab = 840mg administered as a 60-minute intravenous infusion, followed every 3 weeks thereafter by a dose of 420mg administered over a period of 30-60 minutes.

Vemurafenib plus Cobimetinib

Vemurafenib = 960 mg orally every 12 hours.

Cobimetinib = 60 mg orally once daily for 21 days, followed by 7 days of rest

Vismodegib

150mg taken orally, once daily

Tucatinib

300mg taken orally, twice daily

Primary outcome measure

  • Objective response rate defined as the number of patients with complete response or partial response [ Time Frame: 4 years ]

Central Contacts and Locations

Central contacts

Janet Dancey

613-533-6430jdancey@ctg.queensu.ca

Locations

Cross Cancer Institute

Recruiting

Edmonton, Alberta, Canada, T6G 1Z2

Contacts

Quincy Chu

780 432-8248

BCCA - Kelowna

Recruiting

Kelowna, British Columbia, Canada, V1Y 5L3

Contacts

Sara Kristina Taylor

250 712-3996

BCCA - Vancouver

Recruiting

Vancouver, British Columbia, Canada, V5Z 4E6

Contacts

Daniel John Renouf

604 877-6000

Kingston Health Sciences Centre

Recruiting

Kingston, Ontario, Canada, K7L 2V7

London Health Sciences Centre Research Inc.

Recruiting

London, Ontario, Canada, N6A 5W9

Contacts

Stephen Welch

519 685-8640

Ottawa Hospital Research Institute

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Contacts

John Hilton

613 737-7700

University Health Network

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Lillian Siu

416 946-2911

The Jewish General Hospital

Recruiting

Montreal, Quebec, Canada, H3T 1E2

Contacts

Cristiano Ferrario

514 398-8307

Allan Blair Cancer Centre

Recruiting

Regina, Saskatchewan, Canada, S4T 7T1

Contacts

Kimberly Hagel

306 766-2691

Saskatoon Cancer Centre

Recruiting

Saskatoon, Saskatchewan, Canada, S7N 4H4

Contacts

Sunil K. Yadav

306 655-2710

More Information

Sponsor

Canadian Cancer Trials Group

Last update posted

Mar 27, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Canadian Cancer Trials Group on 2026-03-27.